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To Evaluate the Safety of JL18008 (JL18008)

9 июня 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

40

Фаза

  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый

Принимает здоровых добровольцев

Да

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Arm 1: JL18008 1 μg/kg
Single intramuscular injection of JL18008 at 1 μg/kg.
Лекарство: 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.
Плацебо Компаратор: Arm 2: Placebo (for 1 μg/kg group)
Single intramuscular injection of placebo (JL18008 buffer).
Лекарство: 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.
Экспериментальный: Arm 3: JL18008 5 μg/kg
Single intramuscular injection of JL18008 at 5 μg/kg.
Лекарство: 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.
Плацебо Компаратор: Arm 4: Placebo (for 5 μg/kg group)
Single intramuscular injection of placebo.
Лекарство: 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.
Экспериментальный: Arm 5: JL18008 10 μg/kg
Single intramuscular injection of JL18008 at 10 μg/kg.
Лекарство: 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.
Плацебо Компаратор: Arm 6: Placebo (for 10 μg/kg group)
Single intramuscular injection of placebo.
Лекарство: 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.
Экспериментальный: Arm 7: JL18008 20 μg/kg
Single intramuscular injection of JL18008 at 20 μg/kg.
Лекарство: 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.
Плацебо Компаратор: Arm 8: Placebo (for 20 μg/kg group)
Single intramuscular injection of placebo.
Лекарство: 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.
Экспериментальный: Arm 9: JL18008 40 μg/kg
Single intramuscular injection of JL18008 at 40 μg/kg.
Лекарство: 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.
Плацебо Компаратор: Arm 10: Placebo (for 40 μg/kg group)
Single intramuscular injection of placebo.
Лекарство: 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.
Экспериментальный: Arm 11: JL18008 70 μg/kg
Single intramuscular injection of JL18008 at 70 μg/kg.
Лекарство: 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.
Плацебо Компаратор: Arm 12: Placebo (for 70 μg/kg group)
Single intramuscular injection of placebo.
Лекарство: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from Baseline in White Blood Cell Count (WBC)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Up to 56 days
Change from Baseline in Alanine Aminotransferase (ALT)
Up to 56 days
Change from Baseline in Aspartate Aminotransferase (AST)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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⁺)
Временное ограничение: 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⁺)
Временное ограничение: 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⁺)
Временное ограничение: 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⁺)
Временное ограничение: 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-)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Up to 56 days
Change from Baseline in Activated Partial Thromboplastin Time (APTT)
Up to 56 days
Change from Baseline in Prothrombin Time (PT)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Jecho Biopharmaceuticals Co., Ltd.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

13 июня 2024 г.

Первичное завершение (Действительный)

5 августа 2025 г.

Завершение исследования (Действительный)

5 августа 2025 г.

Даты регистрации исследования

Первый отправленный

21 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

4 июня 2026 г.

Первый опубликованный (Действительный)

5 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

11 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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