A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants

Официальное название

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biomarker Characteristics of a Single Subcutaneous Injection of GenSci161 Injection in Healthy Adult Participants

Обзор

To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.

Вмешательства

• Препарат GenSci161
  Administered subcutaneous injection
• Препарат Placebo
  Administered subcutaneous injection

Первичные конечные точки

• Incidence and severity of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) and other safety measures [Срок оценки: Day1- Day183]

Вторичные конечные точки (8)

• Area under the concentration-time curve from zero up to a definite time t (AUC0-t) [Срок оценки: Day1- Day183]
• Area under the concentration-time curve from zero up to infinity (AUC0-∞) [Срок оценки: Day1- Day183]
• Maximum concentration (Cmax) [Срок оценки: Day1- Day183]
• Terminal elimination half-life (t1/2) [Срок оценки: Day1- Day183]
• Apparent clearance (CL/F) [Срок оценки: Day1- Day183]
• Apparent volume of distribution (Vd/F) [Срок оценки: Day1- Day183]
• Anti-drug antibody (ADA) and neutralizing antibody(Nab) [Срок оценки: Day1- Day183]
• Upper limit of the two-sided 90% confidence interval for ∆∆QTcF corresponding to the maximum geometric mean of Cmax obtained from the study [Срок оценки: Day1- Day15]

Критерии участия

Критерии включения

• Healthy adult male or female participants, aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF).
• Male body weight ≥ 50 kg and female body weight ≥ 45 kg at screening; body mass index (BMI) between 18 and 28 kg/m² (inclusive).
• In good general condition as determined by medical history, screening period assessments, such as physical examination, vital signs, ECG, laboratory tests, and imaging examinations, with all results within reference ranges or deemed clinically insignificant by the investigator.
• Male and female participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose. From the time of signing the ICF until 6 months after the last dose, they must have no plans for conception, sperm donation, egg donation, or egg cryopreservation. Female participants must have had no unprotected sexual intercourse within 14 days prior to the first dose.
• Participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.

Критерии исключения

• History of hypersensitivity to GenSci161, any of its excipients, or similar compounds; or a history of allergic diathesis; or a history of allergic diseases.
• Severe trauma or major surgical procedure (e.g., coronary artery bypass grafting, organ resection, gynecological surgery) within 12 months prior to screening, or planning to undergo any surgery (including cosmetic procedures) during the trial period.
• Presence of significant active systemic or local infection (including, but not limited to, bacterial, viral, fungal, or parasitic \[helminth\] infections) at any time from 4 weeks prior to screening until the day of randomization.
• Intolerance to abdominal subcutaneous injection, or the presence of tattoos, sunburn, scars, or any other factors at the intended injection site that may interfere with site assessment.
• History or current presence of any clinically significant, poorly controlled chronic disease or organ dysfunction that, in the investigator's judgment, could compromise the trial's conduct. This includes, but is not limited to, disorders of the following systems: neuropsychiatric, cardiovascular, urological, gastrointestinal, respiratory, musculoskeletal, metabolic, endocrine, hematologic, immunologic, and dermatologic, as well as any other major medical conditions and malignancies (with the exception of adequately treated or resected, and resolved non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin).
• A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (TPPA), or hepatitis B virus (HBV) infection (defined as a positive hepatitis B surface antigen \[HBsAg\] and/or a positive hepatitis B core antibody \[HBcAb\] result).
• Administration of any live or live-attenuated vaccine within 12 weeks prior to screening or planning to receive any live or live-attenuated vaccine (with the exception of inactivated influenza vaccine) during the trial period.
• Any other condition that, in the judgment of the investigator, would make the participant unsuitable for participation in this clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT07476586 · GenSci161-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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