A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults

Официальное название

A Phase I Clinical Study of GS3-007a Dry Suspensions in Healthy Chinese Adults: Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalation, and Food Effect Study

Обзор

This study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.

Вмешательства

• Препарат GS3-007a for Suspension
  GS3-007a dry suspension for oral use. Each sachet contains 50 mg of GS3-007a. The dry suspension is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. The product should be stored protected from light, in a sealed container, at or below 25°C.
• Препарат Placebo GS3-007a for Suspension
  Placebo dry suspension matching GS3-007a in appearance, odor, and packaging. It contains all excipients except the active ingredient, with added bitter agent. It is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. Storage conditions are the same as for the active drug.

Первичные конечные точки

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: up to 6 days (SAD+FE phase), up to 21 days (MAD)]

Вторичные конечные точки (10)

• Pharmacokinetics (PK) Indicators - Maximum Observed Concentration (Cmax) [Срок оценки: up to 6 days (SAD+FE phase)]
• Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration (Tmax) [Срок оценки: up to 6 days (SAD+FE phase)]
• Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Time t (AUC0-t) [Срок оценки: up to 6 days (SAD+FE phase)]
• Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) [Срок оценки: up to 6 days (SAD+FE phase)]
• Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration at Steady State (Tss,max) [Срок оценки: up to 21 days (MAD)]
• Pharmacokinetics (PK) Indicators - Maximum Observed Concentration at Steady State (Css,max) [Срок оценки: up to 21 days (MAD)]
• Pharmacokinetics (PK) Indicators - Minimum Observed Concentration at Steady State (Css,min) [Срок оценки: up to 21 days (MAD)]
• Pharmacokinetics (PK) Indicators - Average Observed Concentration at Steady State (Css,av) [Срок оценки: up to 21 days (MAD)]
• Pharmacodynamics(PD) Indicators [Срок оценки: up to 6 days (SAD+FE phase), up to 21 days (MAD)]
• PD Indicators [Срок оценки: The entire MAD research phase]

Критерии участия

Критерии включения

• Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;
• Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;
• Fully understand the purpose, nature, and methods of the trial, as well as possible adverse reactions, voluntarily participate as subjects, sign the informed consent form (ICF) before any study procedures;
• From screening day to 3 months after the last dose, have no plans for conception or sperm/egg donation, and agree to use reliable non-drug contraception during the trial (such as complete abstinence, intrauterine device, partner sterilization, etc.).

Критерии исключения

• A highly allergic constitution
• Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.
• Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged; abnormal liver function; abnormal findings in physical examination, laboratory tests, or other examinations with clinical significance.
• Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.
• Individuals who are alcoholics or who regularly consumed alcohol within 6 months before the first dose of the trial, or those unwilling to stop drinking or consuming any alcohol-containing products during the entire trial.
• Individuals with a history of heavy smoking or those who smoked an average of ≥5 cigarettes per day within the 3 months before screening
• Individuals with immune deficiencies or immunosuppressive diseases, malignant tumors, chronic cardiovascular, liver, kidney, endocrine, respiratory, hematological (including coagulation), or digestive system diseases.
• Individuals who underwent major surgery within 6 months before screening or during the screening period, or those who experienced acute neurological, digestive, respiratory, circulatory, endocrine, or hematological diseases within 3 months before screening;
• Subjects who have donated blood (including blood components) within 3 months prior to the first dose, or have experienced blood loss ≥ 400 mL within 3 months prior to the first dose
• Subjects who have participated in any clinical trial and used investigational drugs, vaccines, or devices within 3 months prior to screening
• Subjects who have started a significantly abnormal diet within 4 weeks prior to screening or during the screening period, or have special dietary requirements, cannot comply with the standardized diet, or cannot tolerate the high-fat, high-calorie meal in postprandial trials
• Female subjects who are pregnant or breastfeeding

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Yuehong Plaza, No. 88 Hongcao Road, Xuhui District, Shanghai — Шанхай

Идентификаторы

NCT: NCT07473570 · GenSci073-107

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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