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

4 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

40

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
      • Beijing, Chiny
        • Peking Union Medical College Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  1. Voluntary participation in the study, ability to understand and comply with the protocol requirements, and provision of written informed consent.
  2. 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.
  3. Male or female, age 18 to 55 years inclusive.
  4. 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.
  5. No clinically significant history of cardiovascular, hepatic, renal, gastrointestinal, neurological, or hematological disease.
  6. 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:

  1. Any history of allergic disease, or food or drug allergy, that in the investigator's opinion makes the subject unsuitable for inclusion.
  2. 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.
  3. 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.
  4. 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.
  5. Any major illness considered clinically significant by the investigator within 90 days before dosing.
  6. Major surgery within 60 days before dosing, or any surgery within 28 days before dosing.
  7. Fever or infectious illness within 28 days before dosing.
  8. Use of any medication (including prescription, non-prescription, herbal, or dietary supplements) within 14 days before dosing.
  9. Vaccination within 1 month before dosing, or plan to receive vaccination during the study period.
  10. 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).
  11. Daily smoking of more than 5 cigarettes within 3 months before screening, or unable to refrain from smoking during the study.
  12. 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.
  13. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis antibody.
  14. Clinically evident gastrointestinal, hepatic, or renal abnormality that, in the investigator's opinion, may affect drug transport, absorption, distribution, metabolism, or excretion.
  15. 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Arm 1: JL18008 1 μg/kg
Single intramuscular injection of JL18008 at 1 μg/kg.
Lek: 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.
Komparator placebo: Arm 2: Placebo (for 1 μg/kg group)
Single intramuscular injection of placebo (JL18008 buffer).
Lek: 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.
Eksperymentalny: Arm 3: JL18008 5 μg/kg
Single intramuscular injection of JL18008 at 5 μg/kg.
Lek: 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.
Komparator placebo: Arm 4: Placebo (for 5 μg/kg group)
Single intramuscular injection of placebo.
Lek: 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.
Eksperymentalny: Arm 5: JL18008 10 μg/kg
Single intramuscular injection of JL18008 at 10 μg/kg.
Lek: 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.
Komparator placebo: Arm 6: Placebo (for 10 μg/kg group)
Single intramuscular injection of placebo.
Lek: 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.
Eksperymentalny: Arm 7: JL18008 20 μg/kg
Single intramuscular injection of JL18008 at 20 μg/kg.
Lek: 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.
Komparator placebo: Arm 8: Placebo (for 20 μg/kg group)
Single intramuscular injection of placebo.
Lek: 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.
Eksperymentalny: Arm 9: JL18008 40 μg/kg
Single intramuscular injection of JL18008 at 40 μg/kg.
Lek: 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.
Komparator placebo: Arm 10: Placebo (for 40 μg/kg group)
Single intramuscular injection of placebo.
Lek: 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.
Eksperymentalny: Arm 11: JL18008 70 μg/kg
Single intramuscular injection of JL18008 at 70 μg/kg.
Lek: 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.
Komparator placebo: Arm 12: Placebo (for 70 μg/kg group)
Single intramuscular injection of placebo.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in White Blood Cell Count (WBC)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Up to 56 days
Change from Baseline in Alanine Aminotransferase (ALT)
Up to 56 days
Change from Baseline in Aspartate Aminotransferase (AST)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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⁺)
Ramy czasowe: 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⁺)
Ramy czasowe: 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⁺)
Ramy czasowe: 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⁺)
Ramy czasowe: 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-)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Up to 56 days
Change from Baseline in Activated Partial Thromboplastin Time (APTT)
Up to 56 days
Change from Baseline in Prothrombin Time (PT)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Jecho Biopharmaceuticals Co., Ltd.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 czerwca 2024

Zakończenie podstawowe (Rzeczywisty)

5 sierpnia 2025

Ukończenie studiów (Rzeczywisty)

5 sierpnia 2025

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zakażenia wirusem HIV

Badania kliniczne na JL18008 1 μg/kg

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Equatorial Guinea

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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