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A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.

31 oktober 2026 uppdaterad av: Jiangsu Chuangyuan Life Science and Technology Co., Ltd.

A Phase I Clinical Trial to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of CPU-YL01 Injection in Patients With Chronic Hepatitis B

This is a multicenter, randomized, double-blind, placebo-controlled Phase 1 trial. It aims to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CPU-YL01 injection in chronic hepatitis B patients who have received nucleos(t)ide analog therapy. Single-dose and multiple-dose escalations will be conducted in this study

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Kronisk hepatit B

Intervention / Behandling

Detaljerad beskrivning

This study is a multicenter, randomized, double blind, placebo controlled Phase I clinical trial involving single dose and multiple dose, dose-escalation explorations, aimed at evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CPU-YL01 in patients with chronic hepatitis B (CHB) previously treated with nucleos(t)ide analogs (NAs), as well as exploring its effects on biomarkers and immunogenicity, thereby providing a scientific basis for dose selection in Phase II clinical trials. Patients enrolled in this trial must have been previously treated with NAs; during the trial, they shall continue to take their respective NAs at the same regimen including drug class, dosage, and dosing frequency to avoid virological breakthrough due to discontinuation of NAs.

Studietyp

Interventionell

Inskrivning (Beräknad)

Fas

Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Kina
- Beijing Municipality
  - Beijing, Beijing Municipality, Kina, 100069
    - Beijing You'an Hospital, Capital Medical University
  - Beijing, Beijing Municipality, Kina, 102208
    - Beijing Jishuitan Hospital, Capital Medical University
- Henan
  - Zhengzhou, Henan, Kina, 450015
    - Henan Province Infectious Disease Hospital (Zhengzhou Sixth People's Hospital)
- Jiangsu
  - Nanjing, Jiangsu, Kina, 210008
    - Gulou Hospital, Nanjing University Medical School

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

Voluntarily sign the informed consent form (ICF), understand this study, and be willing and able to comply with and complete all trial procedures;
Open to all genders; age range: 18-70 years(inclusive);
The body mass index (BMI) ranges from 18 to 30 kg/m2(including the boundary values);
Clinically diagnosed chronic hepatitis B (serum HBsAg positivity for ≥6 months; outpatient medical records, inpatient medical records, or laboratory test results may serve as evidence);
During the screening phase, the HBsAg test result was ≤10,000 IU/mL (for participants in single-dose studies); or the HBsAg test result was ≤3,000 IU/mL (for participants in multiple-dose studies);
Patients currently receiving a stable dose of monotherapy or combination therapy with one or two nucleos(t)ide analogs for hepatitis B virus (HBV) treatment are required to have had no changes in their nucleos(t)ide analog regimen during the preceding 6 months, and no plans to alter their nucleos(t)ide analog regimen during the trial period. The eligible treatment options are limited to the following five agents: tenofovir alafenamide fumarate (TAF), teltenofovir mesylate (TMF), tenofovir disoproxil fumarate (TDF), prafenomide mesylate tablets (formerly known as paradenomide mesylate tablets; brand name: Xinshumu), or entecavir (ETV);
The HBV DNA test result during the screening phase was negative (below the lower detection limit of the local research center);
Male trial participants and female trial participants of childbearing age shall agree to use effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose.

Exclusion Criteria:

A history of liver cirrhosis (confirmed by liver biopsy), or the presence of complications such as gastroesophageal variceal bleeding, hepatic encephalopathy, or ascites, or a liver stiffness measurement>12.4 kPa during screening;
Presence of other clinically significant liver diseases other than chronic hepatitis B, such as autoimmune hepatitis, toxic hepatitis, hemochromatosis, alcoholic liver disease, drug-induced hepatitis, α1-antitrypsin deficiency, Wilson's disease, etc.;
Use of immunosuppressants or immunomodulators (e.g., thymus) within 6 months prior to the first dose Patients taking peptides or cytotoxic agents, or those who have received corticosteroid therapy (excluding topical, inhalational, or ophthalmic treatments) for at least one week within 6 months prior to the first dose, or those who have had a history of vaccination within 1 month prior to screening or have planned to receive vaccinations during the trial period;
Prior to the first dose, the subject has received interferon or peginterferon therapy within the preceding 6 months, or plans to receive interferon or peginterferon therapy during the trial period;
Positive for hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies, or positive for Treponema pallidum (TP) antibodies with confirmatory positive results on the rapid plasma reagin (RPR) test;
Exclusion criteria include a history of malignant tumor or recurrence within the 5 years prior to the first dose, except for specific cancers that can be cured by surgical resection (e.g., non-melanoma skin cancer, cervical intraepithelial neoplasia, thyroid tumors, breast tumors, etc., that have already been treated and show no signs of recurrence);
Has previously undergone organ transplantation;
Patients with a prior history of myocarditis, pericarditis, or idiopathic cardiomyopathy;
Participants who, at the time of screening, suffer from systemic severe diseases affecting other organs-including but not limited to the gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, or immunological systems (including but not limited to immunodeficiency or immunosuppression), as well as psychiatric or cardiovascular and cerebrovascular diseases-and who have been determined by the study physician to be unsuitable for participation in this trial;
Suffering from a progressive neurological disorder;
Patients with poorly controlled diabetes [fasting plasma glucose>7.0 mmol/L and/or HbA1c ≥7.5%] or hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), for whom the investigator determines that they are unsuitable to participate in this trial;
Patients with a severe allergic constitution, a history of allergies to multiple foods or medications, or a known allergy to the test drug or its excipients;
Subjects who exhibit significant abnormalities in laboratory tests or electrocardiogram (ECG) findings during the screening phase, and whom the investigator determines to be unsuitable for participation in this trial, including but not limited to:
1. ALT or AST ≥ 2×ULN;
2. TBil ≥ 2×ULN and direct bilirubin (DBil)> 1.5×ULN;
3. Albumin <38 g/L;
4. Platelet count <125×10*9/L;
5. Absolute neutrophil count <1.5×10*9/L;
6. Prothrombin time (PT)>3s, or international normalized ratio (INR)>1.3;
7. Creatinine clearance (using the Cockcroft-Gault formula) <60 mL/min;
8. Alpha-fetoprotein (AFP)> 20 μg/L;
9. QTcF> 450 ms (men) or> 470 ms (women);
A history of drug use or alcohol abuse [weekly alcohol consumption exceeding 14 alcohol units (1 alcohol unit = 360 mL of beer, 150 mL of wine, or 45 mL of distilled spirits)];
Having participated in other drug clinical trials and used trial drugs, or having participated in clinical trials of medical devices or vaccines, within 3 months prior to the first dose administration or within 5 drug half-life periods (whichever period is longer);
In this trial, participants who previously participated in the single-dose trial of CPU-YL01 may be re-screened for enrollment during the multiple-dose trial phase; the time limit requirements for prior trial participation of such participants shall be consistent with the exclusion criteria specified in Clause 15.
Women who are pregnant or breastfeeding;
The researchers believe that the subject is unsuitable to participate in this trial due to other reasons.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Fyrdubbla

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm	Intervention / Behandling
Experimentell: CPU-YL01 Injection Intramuscular administration	Läkemedel: CPU-YL01 Injection Intramuscular administration Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
Placebo-jämförare: Placbo Injection Intramuscular administration	Läkemedel: Placebo intramuscular injection Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively. Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.

Deltagargrupp / Arm

Intervention / Behandling

Experimentell: CPU-YL01 Injection

Intramuscular administration

Läkemedel: CPU-YL01 Injection Intramuscular administration

Single-dose study：Each dose group received a single dose of treatment; on day Day1, subjects in all groups received either the test drug CPU-YL01 or a placebo via intramuscular injection. Tolerance evaluation assessments were conducted on days Day2, Day3, Day8, Day15, Day22, and Day29, respectively.

Multiple-dose study：Each dose group received six administrations, with one administration every 4 weeks, specifically via intramuscular injection of the test drug CPU-YL01 or placebo on days Day1, Day29, Day57, Day85, Day113, and Day141. Tolerance evaluation assessments were conducted before administration on days Day2, Day3, Day8, and Day29; before administration on days Day36, Day57, Day85, Day113, and Day141; and on days Day142, Day143, Day148, Day169, Day225, Day281, and Day337.

Placebo-jämförare: Placbo Injection

Intramuscular administration

Läkemedel: Placebo intramuscular injection

Vad mäter studien?

Primära resultatmått

Sekundära resultatmått

Andra resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Cytokines- Concentration of Interleukin (IL)-1α [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.	Cytokines- Concentration of Interleukin (IL)- 1α	Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines-Concentration of Interferon-γ (IFN-γ) [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.	Cytokines-Concentration of Interferon-γ (IFN-γ)	Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines-Concentration of Monocyte chemoattractant protein-1 (MCP-1) [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.	Cytokines-Concentration of Monocyte chemoattractant protein-1 (MCP-1)	Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines- Concentration of Tumor necrosis factor-α (TNF-α) [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.	Cytokines-Concentration of Tumor necrosis factor-α (TNF-α)	Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
Cytokines-Concentration of IL-15 [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.	Cytokines-Concentration of IL-15	Multiple-dose: Day1 (before dosing and 12h after dosing) , Day2, Day8, Day29(second dose), Day57(third dose), Day58, Day141(sixth dose), Day142, Day148, Day169, Day225.
T cells- Using ELISpot to detect HBsAg peptide pools in peripheral blood mononuclear cells (PBMCs) [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).	T cells- Using ELISpot to detect HBsAg peptide pools in peripheral blood mononuclear cells (PBMCs)	Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).
T cells- Antigen-specific cells that produce IFN-γ in response to the Pre-S1 peptide library [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).	T cells- Antigen-specific cells that produce IFN-γ in response to the Pre-S1 peptide library	Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).
T cells- the levels of IFN-γ secreted by CD4 T cells and CD8 T cells under stimulation with HBsAg peptide libraries and Pre-S1 peptide libraries were assessed by flow cytometry [Biomarker Evaluation Metrics] Tidsram: Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).	T cells- the levels of IFN-γ secreted by CD4 T cells and CD8 T cells under stimulation with HBsAg peptide libraries and Pre-S1 peptide libraries were assessed by flow cytometry	Multiple-dose: Before Day1 dosing, at 24 hours post-dosing (Day2, ±1 hour), before Day141 (6th dosing) and at 24 hours post dosing (Day142, ±1 hour), as well as at Day169 (4 weeks after the 6th dosing) and Day225 (12 weeks after the 6th dosing).
titer of anti-drug antibody (ADA) [Immunogenicity Evaluation Metric] Tidsram: Single-dose: before administration on Day1, Day29. Multiple-dose: before administration on Day1, before administration on Day29, before administration on Day85, and on Day169, Day225, and Day337.	titer of anti-drug antibody (ADA)	Single-dose: before administration on Day1, Day29. Multiple-dose: before administration on Day1, before administration on Day29, before administration on Day85, and on Day169, Day225, and Day337.
rate of anti-drug antibody (ADA) [Immunogenicity Evaluation Metric] Tidsram: Single-dose: before administration on Day1, Day29. Multiple-dose: before administration on Day1, before administration on Day29, before administration on Day85, and on Day169, Day225, and Day337.	rate of anti-drug antibody (ADA)	Single-dose: before administration on Day1, Day29. Multiple-dose: before administration on Day1, before administration on Day29, before administration on Day85, and on Day169, Day225, and Day337.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Jiangsu Chuangyuan Life Science and Technology Co., Ltd.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 juli 2026

Primärt slutförande (Beräknad)

4 mars 2027

Avslutad studie (Beräknad)

3 juli 2028

Studieregistreringsdatum

Först inskickad

15 september 2026

Först inskickad som uppfyllde QC-kriterierna

31 oktober 2026

Första postat (Faktisk)

5 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

CPU-YL01-101

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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Resultatmått	Åtgärdsbeskrivning	Tidsram
adverse events [Safety and Tolerability Evaluation Endpoints] Tidsram: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.	adverse events	For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
serious adverse events [Safety and Tolerability Evaluation Endpoints] Tidsram: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.	serious adverse events	For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
adverse events of particular concern (AESI) [Safety and Tolerability Evaluation Endpoints] Tidsram: For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.	adverse events of particular concern (AESI)	For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose.
vital signs-Blood Pressure (mmHg) [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose:Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.	vital signs-Blood Pressure (mmHg)	Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose:Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-respiratory rate (breaths/min) [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.	vital signs-respiratory rate (breaths/min)	Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-body temperature (°C) [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.	vital signs-body temperature (°C)	Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
vital signs-pulse rate (beats/min) [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.	vital signs-pulse rate (beats/min)	Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337.
physical examination- skin- Color abnormalities-jaundice -The number of participants with or without skin Color abnormalities- jaundice [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- skin-Color abnormalities: jaundice. The number of participants with or without skin Color abnormalities: jaundice will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin- Color abnormalities-pallor- The number of participants with or without skin Color abnormalities: pallor [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- skin- Color abnormalities: pallor. The number of participants with or without skin Color abnormalities: pallor will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Color abnormalities-pigmentation- The number of participants with or without skin Color abnormalities:pigmentation [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- skin-Color abnormalities : pigmentation. The number of participants with or without skin Color abnormalities:pigmentation will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities- rash-The number of participants with or without -Morphological abnormalities: rash [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- skin-Morphological abnormalities: rash . The number of participants with or without -Morphological abnormalities: rash will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities-erythema at injection site -The number of participants with or without -Morphological abnormalities: erythema at injection site [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- skin-Morphological abnormalities: erythema at injection site. The number of participants with or without -Morphological abnormalities: erythema at injection site will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- skin-Morphological abnormalities: induration at injection site- The number of participants with or without -Morphological abnormalities: induration at injection site [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- skin-Morphological abnormalities: induration at injection site. The number of participants with or without -Morphological abnormalities: induration at injection site will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Ocular conjunctiva: assessment for scleral icterus- The number of participants with or without -Ocular conjunctiva-scleral icterus [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-mucous membranes- Ocular conjunctiva: assessment for scleral icterus. The number of participants with or without -Ocular conjunctiva-scleral icterus will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Ocular conjunctiva: assessment for conjunctival pallor-The number of participants with or without -Ocular conjunctiva-conjunctival pallor [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-mucous membranes-Ocular conjunctiva: assessment for conjunctival pallor. The number of participants with or without -Ocular conjunctiva-conjunctival pallor will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for petechiae-The number of participants with or without Oral mucosa-petechiae [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-mucous membranes-Oral mucosa: assessment for petechiae. The number of participants with or without Oral mucosa-petechiae will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes-Oral mucosa: assessment for ulceration-The number of participants with or without Oral mucosa-ulceration [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-mucous membranes-Oral mucosa: assessment for ulceration. The number of participants with or without Oral mucosa-ulceration will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-mucous membranes- Oral mucosa: assessment for fungal infection-The number of participants with or without Oral mucosa-fungal infection [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-mucous membranes-Oral mucosa: assessment for fungal infection. The number of participants with or without Oral mucosa-fungal infection will be reported by category.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- lymph nodes enlargement -The number of participants with or without lymph nodes enlargement [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-lymph nodes enlargement. The number of participants with or without lymph nodes enlargement will be reported by category. (Among participants with enlarged lymph nodes, findings for lymph node consistency, mobility and tenderness will also be summarized.)	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes- Lymph Node Consistency(Participants with Enlarged Lymph Nodes)- The number of participants with lymph node consistency- soft, firm, hard. [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-lymph nodes- Assessment of lymph node consistency (soft, firm, hard). Among participants with enlarged lymph nodes, lymph node consistency will be assessed (soft, firm, hard). The number of participants in each consistency category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes-assessment for lymph nodes mobility (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node mobility -mobile, fixed. [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-lymph nodes - Assessment of lymph node mobility (mobile / fixed). Among participants with enlarged lymph nodes, lymph node mobility will be assessed (mobile, fixed). The number of participants in each mobility category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-lymph nodes-assessment for tenderness (Participants with Enlarged Lymph Nodes) -The number of participants with lymph node tenderness tender, non-tender. [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-lymph nodes -assessment for tenderness. Among participants with enlarged lymph nodes, assessment for lymph node tenderness (tender, non-tender). The number of participants in each tenderness category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for dull facies-The number of participants with dull facies [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-head-Face: assessment for dull facies. The number of participants with dull facies will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Face: assessment for facial edema-The number of participants with facial edema [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-head-Face: assessment for facial edema. The number of participants with facial edema will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for eyelid edema-The number of participants with eyelid edema [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-head-Eyes: assessment for eyelid edema. The number of participants with eyelid edema will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-Eyes: assessment for pupillary light reflex-The number of participants with normal, abnormal pupillary light reflex [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-head-Eyes: assessment for pupillary light reflex. Assessment of pupillary light reflex (normal / abnormal). The number of participants with normal, abnormal pupillary light reflex will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-head-assessment for alopecia- The number of participants with alopecia [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-head-assessment for alopecia. The number of participants with alopecia will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid Enlargement- The number of participants with Thyroid Enlargement [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-neck-assessment for Thyroid Enlargement. The number of participants with Thyroid Enlargement will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for Thyroid nodules-The number of participants with Thyroid nodules [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-neck-assessment for Thyroid nodules. The number of participants with Thyroid nodules will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment of tracheal position-The number of participants with tracheal position midline / deviated [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-neck-assessment of tracheal position (midline / deviated). The number of participants in each category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-neck-assessment for nuchal rigidity-The number of participants with nuchal rigidity [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-neck-assessment for nuchal rigidity. The number of participants with nuchal rigidity will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Lungs: assessment of breath sound clarity-The number of participants with lung breath sounds clear, wheezes, rales. [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- chest-Lungs: Assessment of lung breath sounds (clear, wheezes, rales). The number of participants in each category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: assessment of cardiac rhythm regularity-The number of participants with cardiac rhythm regular, irregular. [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- chest-Heart: Assessment of cardiac rhythm (regular / irregular). The number of participants in each category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination- chest-Heart: assessment of cardiac murmur-The number of participants with cardiac murmur present, absent. [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination- chest-Heart: Assessment for cardiac murmur (present / absent). The number of participants in each category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of Palpability of Liver Edge Below Right Midclavicular Costal Margin-The number of participants with the liver edge palpable, not palpable. [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-abdomen-Liver. Abdominal palpation to assess whether the liver edge is palpable below the right midclavicular costal margin (palpable / not palpable). The number of participants in each category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter)(For participants with a palpable liver edge)[Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-abdomen-Liver-Distance of Palpable Liver Edge Below the Right Midclavicular Costal Margin (centimeter). For participants with a palpable liver edge below the right midclavicular costal margin, the subcostal distance will be measured and reported in centimeters. This field will be left blank for participants without a palpable liver edge.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-Liver: assessment of hepatic consistency-The number of participants with hepatic consistency soft, firm, hard.(For participants with a palpable liver edge) [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-abdomen-Liver: assessment of consistency (soft, firm, hard). Among participants with a palpable liver edge below the costal margin, hepatic consistency is assessed (soft, firm, hard). The number of participants in each consistency category will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal wall varices-The number of participants with abdominal wall varices [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-abdomen-assessment for abdominal wall varices.The number of participants with abdominal wall varices will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for abdominal tenderness-The number of participants with abdominal tenderness [Safety and Tolerability Evaluation Endpoints] Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-abdomen-assessment for abdominal tenderness.The number of participants with abdominal tenderness will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.
physical examination-abdomen-assessment for rebound tenderness-The number of participants with rebound tenderness. [Safety and Tolerability Evaluation Endpoints Tidsram: Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.	physical examination-abdomen-assessment for rebound tenderness. The number of participants with rebound tenderness will be reported.	Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337.

Resultatmått	Åtgärdsbeskrivning	Tidsram
Primary pharmacokinetic parameters (After a single/dose administration)-peak concentration (Cmax) [Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-peak concentration (Cmax)	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-time to reach peak concentration (Tmax) [Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-time to reach peak concentration (Tmax)	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve from time 0 to the last measurable concentration time point （AUC0-t） [Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve from time 0 to the last measurable concentration time point （AUC0-t）	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve extrapolated from time 0 to infinity （AUC0-∞）[Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-area under the plasma concentration-time curve extrapolated from time 0 to infinity （AUC0-∞）	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration) elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration) elimination rate constant (λz)	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-elimination half-life（t1/2）[Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-elimination half-life（t1/2）	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent clearance (CL/F) [Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-apparent clearance (CL/F)	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-apparent volume of distribution（Vz/F）[Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-apparent volume of distribution（Vz/F）	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-mean residence time（MRT0-t、MRT0-∞）[Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-mean residence time（MRT0-t、MRT0-∞）	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After a single/dose administration)-percentage of residual area (AUC_%Extrap) [Pharmacokinetic Evaluation Parameters] Tidsram: For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.	Primary pharmacokinetic parameters (After a single/dose administration)-percentage of residual area (AUC_%Extrap)	For single-dose: A total of 9 blood collection time points were established: within 60 minute before dosing (0hour) on Day1, 5 minute after dosing , 1 hour, 2 hour, 4 hour, 6 hour, 24 hour, 48 hour, 168 hour.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state peak concentration(Cmax,ss) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- steady-state peak concentration(Cmax,ss)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state trough concentration (Cmin,ss) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- steady-state trough concentration (Cmin,ss)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean steady-state plasma concentration (Cav,ss) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- mean steady-state plasma concentration (Cav,ss)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state time to peak concentration ( Tmax,ss) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- steady-state time to peak concentration ( Tmax,ss)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- area under the plasma concentration-time curve from time 0 after the last dose to the last measurable concentration time point (AUC0-t,ss) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- area under the plasma concentration-time curve from time 0 after the last dose to the last measurable concentration time point (AUC0-t,ss)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)-area under the plasma concentration-time curve extrapolated from time 0 after the last dose to infinity ( AUC0-∞,ss) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)-area under the plasma concentration-time curve extrapolated from time 0 after the last dose to infinity ( AUC0-∞,ss)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination rate constant (λz) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- elimination rate constant (λz)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- elimination half-life (t1/2,ss) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- elimination half-life (t1/2,ss)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent clearance (CLss/F) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent clearance (CLss/F)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent volume of distribution ( Vz,ss/F) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- steady-state apparent volume of distribution ( Vz,ss/F)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- mean residence time (MRT0-∞) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- mean residence time (MRT0-∞)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- fluctuation coefficient (DF) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- fluctuation coefficient (DF)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary pharmacokinetic parameters (After multiple dosing)- accumulation index (Rac,AUC、Rac,Cmax) [Pharmacokinetic Evaluation Parameters] Tidsram: For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.	Primary pharmacokinetic parameters (After multiple dosing)- accumulation index (Rac,AUC、Rac,Cmax)	For multiple-dose: A total of 21 blood collection time points were established. Day1 (6 time points), Day2, Day3, Day8, Day29 (2nd dose), Day85 (4th dose), and Day113 (5th dose), Day141 (6th dose, 6 time points), Day142, Day143 , Day168.
Primary PD endpoints-quantitative HBsAg [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.	Primary PD endpoints-quantitative HBsAg	Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints-quantitative HBsAb [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.	Primary PD endpoints-quantitative HBsAb	Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative anti-Pre-S1 [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.	Primary PD endpoints--quantitative anti-Pre-S1	Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antigen (HBeAg) [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.	Primary PD endpoints--quantitative hepatitis B e antigen (HBeAg)	Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B e antibody (HBeAb)[Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.	Primary PD endpoints--quantitative hepatitis B e antibody (HBeAb)	Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Primary PD endpoints--quantitative hepatitis B core antibody (HBcAb) [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.	Primary PD endpoints--quantitative hepatitis B core antibody (HBcAb)	Single-dose: Day1(before dosing), Day8, Day15, Day22, and Day29. Multiple-dose: Day1, Day29 (second dose), Day57 (third dose), Day85 (fourth dose), Day113 (fifth dose), Day141 (sixth dose) -before dosing, and Day169, Day225 , Day281, and Day337.
Secondary PD endpoints-HBV DNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.	Secondary PD endpoints-HBV DNA quantification	Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-HBV RNA quantification [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.	Secondary PD endpoints-HBV RNA quantification	Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.
Secondary PD endpoints-hepatitis B core antigen (HBcrAg) quantification [Pharmacodynamic (efficacy) Evaluation Indicators] Tidsram: Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.	Secondary PD endpoints-hepatitis B core antigen (HBcrAg) quantification	Single-dose: Day1(before dosing), and Day29. Multiple-dose: Day1, Day57 (third dose), and Day141 (sixth dose)-before dosing, and Day169, Day225 , Day281 , Day337.

A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.

A Phase I Clinical Trial to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of CPU-YL01 Injection in Patients With Chronic Hepatitis B

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Studerar en amerikansk FDA-reglerad produktprodukt