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To Evaluate the Safety of JL18008 (JL18008)

9 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

40

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm 1: JL18008 1 μg/kg
Single intramuscular injection of JL18008 at 1 μg/kg.
Médicament: 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.
Comparateur placebo: Arm 2: Placebo (for 1 μg/kg group)
Single intramuscular injection of placebo (JL18008 buffer).
Médicament: 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.
Expérimental: Arm 3: JL18008 5 μg/kg
Single intramuscular injection of JL18008 at 5 μg/kg.
Médicament: 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.
Comparateur placebo: Arm 4: Placebo (for 5 μg/kg group)
Single intramuscular injection of placebo.
Médicament: 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.
Expérimental: Arm 5: JL18008 10 μg/kg
Single intramuscular injection of JL18008 at 10 μg/kg.
Médicament: 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.
Comparateur placebo: Arm 6: Placebo (for 10 μg/kg group)
Single intramuscular injection of placebo.
Médicament: 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.
Expérimental: Arm 7: JL18008 20 μg/kg
Single intramuscular injection of JL18008 at 20 μg/kg.
Médicament: 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.
Comparateur placebo: Arm 8: Placebo (for 20 μg/kg group)
Single intramuscular injection of placebo.
Médicament: 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.
Expérimental: Arm 9: JL18008 40 μg/kg
Single intramuscular injection of JL18008 at 40 μg/kg.
Médicament: 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.
Comparateur placebo: Arm 10: Placebo (for 40 μg/kg group)
Single intramuscular injection of placebo.
Médicament: 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.
Expérimental: Arm 11: JL18008 70 μg/kg
Single intramuscular injection of JL18008 at 70 μg/kg.
Médicament: 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.
Comparateur placebo: Arm 12: Placebo (for 70 μg/kg group)
Single intramuscular injection of placebo.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v5.0
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in White Blood Cell Count (WBC)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Up to 56 days
Change from Baseline in Alanine Aminotransferase (ALT)
Up to 56 days
Change from Baseline in Aspartate Aminotransferase (AST)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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⁺)
Délai: 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⁺)
Délai: 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⁺)
Délai: 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⁺)
Délai: 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-)
Délai: 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)
Délai: 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)
Délai: Up to 56 days
Change from Baseline in Activated Partial Thromboplastin Time (APTT)
Up to 56 days
Change from Baseline in Prothrombin Time (PT)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Jecho Biopharmaceuticals Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 juin 2024

Achèvement primaire (Réel)

5 août 2025

Achèvement de l'étude (Réel)

5 août 2025

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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