To Evaluate the Safety of JL18008 (JL18008)
2026年6月9日 更新者：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.
調査の概要
状態
完了
条件
介入・治療
研究の種類
介入
入学 (実際)
40
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Beijing、中国
- Peking Union Medical College Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm 1: JL18008 1 μg/kg
Single intramuscular injection of JL18008 at 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.
|
|
プラセボコンパレーター：Arm 2: Placebo (for 1 μg/kg group)
Single intramuscular injection of placebo (JL18008 buffer).
|
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.
|
|
実験的：Arm 3: JL18008 5 μg/kg
Single intramuscular injection of JL18008 at 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.
|
|
プラセボコンパレーター：Arm 4: Placebo (for 5 μg/kg group)
Single intramuscular injection of placebo.
|
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.
|
|
実験的：Arm 5: JL18008 10 μg/kg
Single intramuscular injection of JL18008 at 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.
|
|
プラセボコンパレーター：Arm 6: Placebo (for 10 μg/kg group)
Single intramuscular injection of placebo.
|
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.
|
|
実験的：Arm 7: JL18008 20 μg/kg
Single intramuscular injection of JL18008 at 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.
|
|
プラセボコンパレーター：Arm 8: Placebo (for 20 μg/kg group)
Single intramuscular injection of placebo.
|
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.
|
|
実験的：Arm 9: JL18008 40 μg/kg
Single intramuscular injection of JL18008 at 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.
|
|
プラセボコンパレーター：Arm 10: Placebo (for 40 μg/kg group)
Single intramuscular injection of placebo.
|
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.
|
|
実験的：Arm 11: JL18008 70 μg/kg
Single intramuscular injection of JL18008 at 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.
|
|
プラセボコンパレーター：Arm 12: Placebo (for 70 μg/kg group)
Single intramuscular injection of placebo.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in White Blood Cell Count (WBC)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Up to 56 days
|
Change from Baseline in Alanine Aminotransferase (ALT)
|
Up to 56 days
|
|
Change from Baseline in Aspartate Aminotransferase (AST)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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⁺)
時間枠：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⁺)
時間枠：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⁺)
時間枠：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⁺)
時間枠：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-)
時間枠：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)
時間枠：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)
時間枠：Up to 56 days
|
Change from Baseline in Activated Partial Thromboplastin Time (APTT)
|
Up to 56 days
|
|
Change from Baseline in Prothrombin Time (PT)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年6月13日
一次修了 (実際)
2025年8月5日
研究の完了 (実際)
2025年8月5日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- JL18008-HV/HIV INR-101（Ia）
- CTR20241578 (レジストリ識別子：Drug Clinical Trial Registration and Information Disclosure Platform, Center for Drug Evaluation, NMPA, China)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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