NCT04965337已完成1 期
A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC of ASC42
研究概览
简要总结
This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers aged 18-55 years.
- •19kg/m2 ≤ BMI <24kg/m
排除标准
- •A positive HBsAg, HCV Ab and/or HIV Ab.
- •Pancreatic injury or pancreatitis.
- •History of organ transplantation, including bone marrow transplantation.
研究组 & 干预措施
ASC42 Dose A
Experimental
ASC42 tablet Dose A, once daily
干预措施: ASC42 (Drug)
Placebo Dose A
Placebo Comparator
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
干预措施: Placebo (Drug)
ASC42 Dose B
Experimental
ASC42 tablet Dose B, once daily
干预措施: ASC42 (Drug)
Placebo Dose B
Placebo Comparator
Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
AUC of ASC42
时间窗: Up to 4 days
Evaluate the Area under the plasma concentration versus time curve.
Cmax of ASC42
时间窗: Up to 4 days
Evaluate the Peak Plasma Concentration.
次要结局
- t1/2 of ASC42(Up to 4 days)
- CL/F of ASC42(Up to 4 days)
- Vd/F of ASC42(Up to 4 days)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Up to 7 days)
研究者
研究点 (1)
Loading locations...
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