A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.
详细描述
The study will consist of 8 cohorts, each with different doses of ASC47.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAD in healthy subjects-Cohort 1
SAD cohort 1, dose 1
干预措施: ASC47 (Drug)
SAD in healthy subjects-Cohort 1
SAD cohort 1, dose 1
干预措施: Matching placebo (Drug)
SAD in healthy subjects-Cohort 2
SAD Cohort 2, dose 2
干预措施: ASC47 (Drug)
SAD in healthy subjects-Cohort 2
SAD Cohort 2, dose 2
干预措施: Matching placebo (Drug)
SAD in healthy subjects-Cohort 3
SAD Cohort 3, dose 3
干预措施: ASC47 (Drug)
SAD in healthy subjects-Cohort 3
SAD Cohort 3, dose 3
干预措施: Matching placebo (Drug)
SAD in patients with obesity-Cohort 3A
SAD Cohort 3A, dose 3
干预措施: ASC47 (Drug)
SAD in patients with obesity-Cohort 3A
SAD Cohort 3A, dose 3
干预措施: Matching placebo (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: up to 57 days
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.
ECG QT Interval
时间窗: up to 57 days
Evaluate the ECG QT Interval after single doses of ASC47.
Hematology
时间窗: up to 57 days
Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
Blood cell
时间窗: up to 57 days
Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.
次要结局
- Cmin of ASC47(up to 57 days)
- Cmax of ASC47(up to 57 days)
- CL/F of ASC47(up to 57 days)
- T1/2 of ASC47(up to 57 days)
- Lipid parameters(up to 57 days)
- AUC of ASC47(up to 57 days)
- Vd/F of ASC47(up to 57 days)