NCT04686994已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese 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
- 20
- 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
The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •23kg/m2 ≤ BMI <40kg/m
排除标准
- •A history of thyroid disease.
- •A positive HBsAg, HCV Ab and/or HIV Ab.
研究组 & 干预措施
ASC41
Experimental
ASC41 two tablets, once daily, from Day 1 to Day 28.
干预措施: ASC 41 (Drug)
ASC41 placebo
Placebo Comparator
ASC41 placebo two tablets, once daily, from Day 1 to Day 28.
干预措施: ASC 41 Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Up to 28 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 28 days
次要结局
- LDL-C and other lipid parameters(Up to 28 days)
- AUC of ASC41(Up to 28 days)
- Cmax of ASC41(Up to 28 days)
- t1/2 of ASC41(Up to 28 days)
- Vd/F of ASC41(Up to 28 days)
- CL/F of ASC41(Up to 28 days)
- Tmax of ASC41(Up to 28 days)
研究者
研究点 (1)
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