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A Study to Evaluate JL18008 in Healthy Adult Subjects (JL18008)

4. Juni 2026 aktualisiert von: Jecho Biopharmaceuticals Co., Ltd.

Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study

This study is being conducted in healthy adult volunteers to evaluate the safety and tolerability of a single injection of an investigational drug called JL18008. The study also examines how the body processes the drug and how it affects immune cells. Participants receive one intramuscular injection of either JL18008 at one of six dose levels (1, 5, 10, 20, 40, or 70 μg/kg) or a placebo (an inactive substance). The study is randomized, double-blind, and placebo-controlled, meaning participants and study staff do not know who receives the active drug or placebo. Blood samples are collected over 56 days to measure drug levels, immune cell counts (such as CD4⁺ T cells), and any antibodies that may form against the drug. The goal is to find a safe dose that can be tested in future studies of people with HIV who have low CD4⁺ T cells despite antiviral treatment.

Studienübersicht

Status

Abgeschlossen

Bedingungen

HIV-Infektionen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

Phase

Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

China
- - Beijing, China
    - Peking Union Medical College Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Erwachsene

Akzeptiert gesunde Freiwillige

Beschreibung

Inclusion Criteria:

Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent.
Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests (hematology, urinalysis, serum chemistry, infectious disease screening, coagulation) are normal or have no clinically significant abnormality.
Male or female, age 18 to 55 years inclusive.
Body weight: male ≥50.0 kg, female ≥45.0 kg. Body mass index (BMI) between 18.0 and 26.0 kg/m² inclusive. BMI = weight (kg) / height (m)².
No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease.
No plans for pregnancy within 6 months, and agreement to use effective contraception with their partner from screening until 3 months after the study completion. No donation of sperm or eggs during this period.

Exclusion Criteria:

Any history of allergic disease, or food or drug allergy, that in the investigator's opinion makes the subject unsuitable for inclusion.
Lactating women; women of childbearing potential with menstrual disorders within 90 days before dosing; women of childbearing potential who had unprotected intercourse with a male partner within 28 days before dosing.
Participation in any clinical trial of an investigational drug within 90 days before dosing, or still within the safety washout period of a previous trial on the day of dosing.
Non-physiological blood loss of ≥200 mL (including trauma, blood draw, blood donation) within 60 days before dosing, or plan to donate blood during the study or within 30 days after dosing.
Any major illness considered clinically significant by the investigator within 90 days before dosing.
Major surgery within 60 days before dosing, or any surgery within 28 days before dosing.
Fever or infectious illness within 28 days before dosing.
Use of any medication (including prescription, non-prescription, herbal, or dietary supplements) within 14 days before dosing.
Vaccination within 1 month before dosing, or plan to receive vaccination during the study period.
History or dependence of alcohol or drug abuse, or drug use, or a positive urine drug screen at screening. Alcohol abuse defined as average weekly intake >21 standard alcohol units. One standard unit contains 14 g of alcohol (e.g., 360 mL of 5% beer, 45 mL of 40% spirits, or 120 mL of 12% wine).
Daily smoking of more than 5 cigarettes within 3 months before screening, or unable to refrain from smoking during the study.
Vital signs at screening meeting any of the following: systolic blood pressure <90 mmHg or >140 mmHg; diastolic blood pressure <50 mmHg or >90 mmHg; pulse rate <50 beats/min or >100 beats/min.
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis antibody.
Clinically evident gastrointestinal, hepatic, or renal abnormality that, in the investigator's opinion, may affect drug transport, absorption, distribution, metabolism, or excretion.
Any other condition that, in the investigator's judgment, might affect the study results or interfere with the subject's participation throughout the study, including but not limited to other medical history (e.g., psychiatric disorder), abnormalities in vital signs, physical examination, electrocardiogram, or clinical laboratory tests.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: Zufällig
Interventionsmodell: Sequenzielle Zuweisung
Maskierung: Verdreifachen

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Experimental: Arm 1: JL18008 1 μg/kg Single intramuscular injection of JL18008 at 1 μg/kg.	Arzneimittel: JL18008 1 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 1 μg/kg.
Placebo-Komparator: Arm 2: Placebo (for 1 μg/kg group) Single intramuscular injection of placebo (JL18008 buffer).	Arzneimittel: Placebo (for 1 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 1 μg/kg.
Experimental: Arm 3: JL18008 5 μg/kg Single intramuscular injection of JL18008 at 5 μg/kg.	Arzneimittel: JL18008 5 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 5 μg/kg.
Placebo-Komparator: Arm 4: Placebo (for 5 μg/kg group) Single intramuscular injection of placebo.	Arzneimittel: Placebo (for 5 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 5 μg/kg.
Experimental: Arm 5: JL18008 10 μg/kg Single intramuscular injection of JL18008 at 10 μg/kg.	Arzneimittel: JL18008 10 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 10 μg/kg.
Placebo-Komparator: Arm 6: Placebo (for 10 μg/kg group) Single intramuscular injection of placebo.	Arzneimittel: Placebo (for 10 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 10 μg/kg.
Experimental: Arm 7: JL18008 20 μg/kg Single intramuscular injection of JL18008 at 20 μg/kg.	Arzneimittel: JL18008 20 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 20 μg/kg.
Placebo-Komparator: Arm 8: Placebo (for 20 μg/kg group) Single intramuscular injection of placebo.	Arzneimittel: Placebo (for 20 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 20 μg/kg.
Experimental: Arm 9: JL18008 40 μg/kg Single intramuscular injection of JL18008 at 40 μg/kg.	Arzneimittel: JL18008 40 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 40 μg/kg.
Placebo-Komparator: Arm 10: Placebo (for 40 μg/kg group) Single intramuscular injection of placebo.	Arzneimittel: Placebo (for 40 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 40 μg/kg.
Experimental: Arm 11: JL18008 70 μg/kg Single intramuscular injection of JL18008 at 70 μg/kg.	Arzneimittel: JL18008 70 μg/kg Recombinant human serum albumin/human interleukin-7 fusion protein (JL18008). Supplied as a solution for injection at 2.5 mg/mL. Administered as a single intramuscular injection at a dose of 70 μg/kg.
Placebo-Komparator: Arm 12: Placebo (for 70 μg/kg group) Single intramuscular injection of placebo.	Arzneimittel: Placebo (for 70 μg/kg Group) JL18008 injection buffer (contains the same excipients as the active drug without the active ingredient). Supplied as a solution for injection. Administered as a single intramuscular injection at a volume matching the active dose of 70 μg/kg.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0 Zeitfenster: Up to 56 days	Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). AEs graded according to NCI CTCAE version 5.0. Assessed from Day 1 through Day 56.	Up to 56 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change from Baseline in White Blood Cell Count (WBC) Zeitfenster: Up to 56 days	Change from baseline in white blood cell count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Neutrophil Count (NEUT) Zeitfenster: Up to 56 days	Change from baseline in neutrophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Eosinophil Count (EOS) Zeitfenster: Up to 56 days	Change from baseline in eosinophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Basophil Count (BASO) Zeitfenster: Up to 56 days	Change from baseline in basophil count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Lymphocyte Count (LYMPH) Zeitfenster: Up to 56 days	Change from baseline in lymphocyte count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Red Blood Cell Count (RBC) Zeitfenster: Up to 56 days	Change from baseline in red blood cell count. Measured in 10¹²/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Hemoglobin (HGB) Zeitfenster: Up to 56 days	Change from baseline in hemoglobin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Platelet Count (PLT) Zeitfenster: Up to 56 days	Change from baseline in platelet count. Measured in 10⁹/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Hematocrit (HCT) Zeitfenster: Up to 56 days	Change from baseline in hematocrit. Measured as a percentage (%). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Bilirubin (TBIL) Zeitfenster: Up to 56 days	Change from baseline in total bilirubin. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Protein (TP) Zeitfenster: Up to 56 days	Change from baseline in total protein. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Albumin (ALB) Zeitfenster: Up to 56 days	Change from baseline in albumin. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Alanine Aminotransferase (ALT) Zeitfenster: Up to 56 days	Change from Baseline in Alanine Aminotransferase (ALT)	Up to 56 days
Change from Baseline in Aspartate Aminotransferase (AST) Zeitfenster: Up to 56 days	Change from baseline in aspartate aminotransferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Gamma-Glutamyl Transferase (γ-GT) Zeitfenster: Up to 56 days	Change from baseline in gamma-glutamyl transferase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Creatinine (Cr) Zeitfenster: Up to 56 days	Change from baseline in creatinine. Measured in μmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Total Cholesterol (TCHO) Zeitfenster: Up to 56 days	Change from baseline in total cholesterol. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Triglycerides (TG) Zeitfenster: Up to 56 days	Change from baseline in triglycerides. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Blood Urea Nitrogen (BUN)/Urea Zeitfenster: Up to 56 days	Change from baseline in blood urea nitrogen. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Alkaline Phosphatase (ALP) Zeitfenster: Up to 56 days	Change from baseline in alkaline phosphatase. Measured in U/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Blood Glucose (GLU) Zeitfenster: Up to 56 days	Change from baseline in blood glucose. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Phosphorus (Pi) Zeitfenster: Up to 56 days	Change from baseline in serum phosphorus. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Sodium (Na⁺) Zeitfenster: Up to 56 days	Change from baseline in serum sodium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Potassium (K⁺) Zeitfenster: Up to 56 days	Change from baseline in serum potassium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Calcium (Ca²⁺) Zeitfenster: Up to 56 days	Change from baseline in serum calcium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Magnesium (Mg²⁺) Zeitfenster: Up to 56 days	Change from baseline in serum magnesium. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Serum Chloride (Cl-) Zeitfenster: Up to 56 days	Change from baseline in serum chloride. Measured in mmol/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in International Normalized Ratio (INR) Zeitfenster: Up to 56 days	Change from baseline in international normalized ratio. Unitless ratio. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Activated Partial Thromboplastin Time (APTT) Zeitfenster: Up to 56 days	Change from Baseline in Activated Partial Thromboplastin Time (APTT)	Up to 56 days
Change from Baseline in Prothrombin Time (PT) Zeitfenster: Up to 56 days	Change from baseline in prothrombin time. Measured in seconds. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Fibrinogen (FIB) Zeitfenster: Up to 56 days	Change from baseline in fibrinogen. Measured in g/L. Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in ECG Parameter: QTcF Interval Zeitfenster: Up to 56 days	Change from baseline in the QT interval corrected for heart rate using Fridericia's formula (QTcF). Measured in milliseconds (ms). Assessed at baseline and on Days 2, 5, 8, 15, 29, and 56.	Up to 56 days
Change from Baseline in Systolic Blood Pressure (SBP) Zeitfenster: Up to 56 days	Change from baseline in systolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Change from Baseline in Diastolic Blood Pressure (DBP) Zeitfenster: Up to 56 days	Change from baseline in diastolic blood pressure. Measured in mmHg. Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Change from Baseline in Pulse Rate Zeitfenster: Up to 56 days	Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and on Days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, and 56.	Up to 56 days
Peak Plasma Concentration (Cmax) - Single Dose Zeitfenster: Up to 672 hours after first dose	Maximum observed plasma concentration following single intramuscular injection. Measured in pg/mL. Assessed at pre-dose and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.	Up to 672 hours after first dose
Time to Reach Peak Plasma Concentration (Tmax) - Single Dose Zeitfenster: Up to 672 hours after first dose	Time to reach maximum observed plasma concentration. Measured in hours (h). Same time points as Cmax.	Up to 672 hours after first dose
Elimination Half-Life (t½) - Single Dose Zeitfenster: Up to 672 hours after first dose	Elimination half-life calculated as ln(2)/λz. Measured in hours (h).	Up to 672 hours after first dose
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC₀-ₗₐₛₜ) - Single Dose Zeitfenster: Up to 672 hours after first dose	AUC using linear trapezoidal rule. Measured in h·pg/mL.	Up to 672 hours after first dose
Area Under the Curve from Time 0 to Infinity (AUC₀-∞) - Single Dose Zeitfenster: Up to 672 hours after first dose	Extrapolated AUC. Measured in h·pg/mL.	Up to 672 hours after first dose
Area Under the Curve from Time 0 to 168 Hours (AUC₀-₁₆₈ₕ) - Single Dose Zeitfenster: Up to 168 hours after first dose	AUC from 0 to 168 hours post-dose. Measured in h·pg/mL.	Up to 168 hours after first dose
Apparent Clearance (CL/F) - Single Dose Zeitfenster: Up to 672 hours after first dose	Dose divided by AUC₀-∞. Measured in L/h.	Up to 672 hours after first dose
Apparent Volume of Distribution (Vz/F) - Single Dose Zeitfenster: Up to 672 hours after first dose	Dose divided by (λz × AUC₀-∞). Measured in L.	Up to 672 hours after first dose
Change from Baseline in CD4⁺ T Cell Count Zeitfenster: Up to 56 days	Change from baseline in absolute CD4⁺ T cell count. Measured in cells/μL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1320 hours post-dose.	Up to 56 days
Change from Baseline in CD8⁺ T Cell Count Zeitfenster: Up to 56 days	Change from baseline in absolute CD8⁺ T cell count. Measured in cells/μL. Same time points as CD4⁺.	Up to 56 days
Change from Baseline in CD4/CD8 T Cell Ratio Zeitfenster: Up to 56 days	Change from baseline in the ratio of CD4⁺ to CD8⁺ T cells. Unitless ratio. Same time points as CD4⁺.	Up to 56 days
Change from Baseline in Serum Interleukin-2 (IL-2) Level Zeitfenster: Up to 672 hours (28 days)	Change from baseline in serum IL-2 level. Measured in pg/mL. Assessed at baseline and at 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 hours post-dose.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-4 (IL-4) Level Zeitfenster: Up to 672 hours (28 days)	Change from baseline in serum IL-4 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-6 (IL-6) Level Zeitfenster: Up to 672 hours (28 days)	Change from baseline in serum IL-6 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-8 (IL-8) Level Zeitfenster: Up to 672 hours (28 days)	Change from baseline in serum IL-8 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interleukin-10 (IL-10) Level Zeitfenster: Up to 672 hours (28 days)	Change from baseline in serum IL-10 level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Tumor Necrosis Factor-alpha (TNF-α) Level Zeitfenster: Up to 672 hours (28 days)	Change from baseline in serum TNF-α level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Change from Baseline in Serum Interferon-gamma (IFN-γ) Level Zeitfenster: Up to 672 hours (28 days)	Change from baseline in serum IFN-γ level. Measured in pg/mL. Same time points as IL-2.	Up to 672 hours (28 days)
Number of Participants with Anti-Drug Antibodies (ADA) Zeitfenster: Up to 56 days	Incidence of anti-drug antibodies (ADA) against JL18008. For ADA-positive participants, titers and neutralizing antibodies (Nab) will be assessed. Assessed at baseline and at 168, 336, 504, 672, 1320 hours post-dose.	Up to 56 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jecho Biopharmaceuticals Co., Ltd.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Juni 2024

Primärer Abschluss (Tatsächlich)

5. August 2025

Studienabschluss (Tatsächlich)

5. August 2025

Studienanmeldedaten

Zuerst eingereicht

21. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

5. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

JL18008-HV/HIV INR-101（Ia）
CTR20241578 (Registrierungskennung: Drug Clinical Trial Registration and Information Disclosure Platform, Center for Drug Evaluation, NMPA, China)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Haisco Pharmaceutical Group Co., Ltd.

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Urämischer Juckreiz

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Daiichi Sankyo, Inc.

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Kachexie

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Haisco Pharmaceutical Group Co., Ltd.

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Analgesie

China
Hanmi Pharmaceutical Company Limited

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Gesund

Korea, Republik von
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Abgeschlossen

RAB001（LLP2A-Ale） bei gesunden Probanden (LLP2A-Ale)

Osteonekrose des Femurkopfes

China
Baylor College of Medicine
George Washington University; Children's National Research Institute

Abgeschlossen

Sicherheit und Immunogenität eines Impfstoffkandidaten für den menschlichen Hakenwurm mit unterschiedlichen Dosen eines neuartigen Adjuvans

Hakenwurminfektion | Hakenwurmkrankheit

Vereinigte Staaten

A Study to Evaluate JL18008 in Healthy Adult Subjects (JL18008)

Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase Ia Clinical Study

Studienübersicht

Status

Bedingungen

Intervention / Behandlung

Studientyp

Einschreibung (Tatsächlich)

Phase

Kontakte und Standorte

Studienorte

Teilnahmekriterien

Zulassungskriterien

Studienberechtigtes Alter

Akzeptiert gesunde Freiwillige

Beschreibung

Studienplan

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm

Intervention / Behandlung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme

Maßnahmenbeschreibung

Zeitfenster

Sekundäre Ergebnismessungen

Ergebnis Maßnahme

Maßnahmenbeschreibung

Zeitfenster

Mitarbeiter und Ermittler

Sponsor

Studienaufzeichnungsdaten

Haupttermine studieren

Studienbeginn (Tatsächlich)

Primärer Abschluss (Tatsächlich)

Studienabschluss (Tatsächlich)

Studienanmeldedaten

Zuerst eingereicht

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Zuerst gepostet (Tatsächlich)

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Zuletzt verifiziert

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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Klinische Studien zur JL18008 1 μg/kg

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Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

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Bedingungen

Seltene Krankheiten

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