Phase I Randomized, Double-blind, Placebo-controlled, Single Multiple Dosing, Dose Escalation, and Food Effect Study of GS3-007A Oral Liquid in Chinese Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- TEAEs
研究概览
简要总结
To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
详细描述
This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Healthy adult subjects aged 18-45 years (including boundary values), male and female;
- •Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;
排除标准
- •Patients with a history of substance abuse and substance dependence;
- •Family history of sudden death;
研究组 & 干预措施
GS3-007 oral liquid
78 subjects: Part 1 SAD 36 subjects: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose.
Part 2 MAD 30 subjects: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days Part 3 Food effects 12 subjects: Planned in 1.6mg/kg dose group。Once a day, a total of one dose.
干预措施: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication (Drug)
Placebo GS3-007 oral liquid
Part 1 SAD: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose.
Part 2 MAD: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days
干预措施: GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication (Drug)
结局指标
主要结局
TEAEs
时间窗: Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;
Adverse events during treatment：Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.
次要结局
- PK characteristics(Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;)