A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC42 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
This is a first in human study of single and multiple ascending doses and food effect of ASC42.
This study consists of 8 cohorts and is divided as follows:
Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between 18 to 65 years of age.
- •Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m
- •Physical examination and vital signs are within normal range or slightly abnormal.
排除标准
- •History or current liver disease, or liver injuries.
- •A positive HBsAg, HCV Ab and/or HIV Ab.
- •Platelet count <150,000/mcL
- •INR> 1.2
研究组 & 干预措施
Single Ascending Dose-ASC42
ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration
干预措施: ASC42 (Drug)
Multiple Ascending Dose-ASC42
ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days
干预措施: ASC42 (Drug)
Single Ascending Dose-Placebo
Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration
干预措施: Placebo (Drug)
Multiple Ascending Dose-Placebo
Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Up to 21 days
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 21 days
次要结局
- Cmax of ASC42(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)
- Vd/F of ASC42(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)
- C4(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)
- FGF19(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)
- t1/2 of ASC42(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)
- AUC of ASC42(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)
- CL/F of ASC42(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)
- Tmax of ASC42(On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.)