NCT07473570招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.).
排除标准
- •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
研究组 & 干预措施
Placebo (SAD/FE)
Placebo Comparator
干预措施: Placebo GS3-007a for Suspension (Drug)
GS3-007a- dose level 1 (MAD)
Experimental
干预措施: GS3-007a for Suspension (Drug)
GS3-007a- dose level 1 (SAD/FE)
Experimental
干预措施: GS3-007a for Suspension (Drug)
GS3-007a- dose level 2 (SAD/FE)
Experimental
干预措施: GS3-007a for Suspension (Drug)
GS3-007a- dose level 2 (MAD)
Experimental
干预措施: GS3-007a for Suspension (Drug)
Placebo (MAD)
Placebo Comparator
干预措施: Placebo GS3-007a for Suspension (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: up to 6 days (SAD+FE phase), up to 21 days (MAD)
次要结局
- Pharmacokinetics (PK) Indicators - Maximum Observed Concentration (Cmax)(up to 6 days (SAD+FE phase))
- Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration (Tmax)(up to 6 days (SAD+FE phase))
- Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Time t (AUC0-t)(up to 6 days (SAD+FE phase))
- Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞)(up to 6 days (SAD+FE phase))
- Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration at Steady State (Tss,max)(up to 21 days (MAD))
- Pharmacokinetics (PK) Indicators - Maximum Observed Concentration at Steady State (Css,max)(up to 21 days (MAD))
- Pharmacokinetics (PK) Indicators - Minimum Observed Concentration at Steady State (Css,min)(up to 21 days (MAD))
- Pharmacokinetics (PK) Indicators - Average Observed Concentration at Steady State (Css,av)(up to 21 days (MAD))
- Pharmacodynamics(PD) Indicators(up to 6 days (SAD+FE phase), up to 21 days (MAD))
- PD Indicators(The entire MAD research phase)
研究者
研究点 (1)
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