Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.

Официальное название

A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China

Обзор

This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.

Вмешательства

• Препарат GenSci120
  a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
• Препарат Placebo
  a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level

Первичные конечные точки

• TEAEs [Срок оценки: 169 days]
• SAEs [Срок оценки: 169 days]
• CSfadf [Срок оценки: 169 days]

Вторичные конечные точки (11)

• plasma [Срок оценки: 169 days]
• AUC0-t, AUC0-∞ [Срок оценки: 169 days]
• Tmax [Срок оценки: 169 days]
• Cmax [Срок оценки: 169 days]
• t1/2 [Срок оценки: half-life]
• CL/F [Срок оценки: apparent clearance]
• V/F [Срок оценки: 169 days]
• RO of T cell subset [Срок оценки: 169 days]
• cell counts of T cell subset [Срок оценки: 169 days]
• Incidence of ADA [Срок оценки: 169 days]
• Time of ADA [Срок оценки: 169 days]

Критерии участия

Критерии включения

• Ages 18-55; ≥3 per gender for each cohort.
• BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
• No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
• Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH >40 IU/L).
• Able to provide informed consent; willing to comply with all study requirements

Критерии исключения

• Allergy to GenSci120 or severe allergies.
• Injection site issues affecting evaluation.
• Significant medical conditions impacting study outcome.
• History of malignant tumors, including listed cancers.
• Seizure history, head injury causing unconsciousness.
• Psychiatric disorders impairing daily activities or cognitive issues.
• Severe immunodeficiency (e.g., HIV).
• Recent trauma, surgery, or GI issues affecting absorption.
• Recent severe infections or antimicrobial treatments.
• Live vaccines within a month prior to screening.
• Abnormal vital signs/ECG: BP extremes, QTcF >450ms.
• Positive for hepatitis B/C, HIV, syphilis during screening.
• Positive TB test via IGRA.
• Recent use of immunosuppressive or targeted therapies.
• Medication use within 14 days prior to randomization.
• Participation in other clinical trials recently/currently.
• Excessive alcohol consumption (over six months).
• Heavy smoking, unwillingness to quit, positive nicotine tests.
• Positive drug screen for specific substances.
• Recent soft/hard drug use within specified periods.
• Blood donation/product receipt recently or poor venous access.
• Study staff involved in the trial.
• Other conditions deemed unsuitable by investigators.

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

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT07040930 · GenSci120-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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