A Phase I Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
研究概览
简要总结
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.
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
- 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
- •Have provided informed consent before initiation of any study-specific procedures.
- •Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
- •No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
排除标准
- •Have evidence of any clinically significant active or chronic disease.
- •Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
- •Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- •Have a history of acute or chronic pancreatitis.
- •Participants with a known clinically significant gastric emptying abnormality.
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- •Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
研究组 & 干预措施
MAD Cohort 2
MAD dose 2
干预措施: Placebo (Other)
MAD Cohort 3
MAD dose 3
干预措施: ASC30 (Drug)
MAD Cohort 3
MAD dose 3
干预措施: Placebo (Other)
SAD Cohort 1
SAD dose 1
干预措施: ASC30 (Drug)
SAD Cohort 1
SAD dose 1
干预措施: Placebo (Other)
SAD Cohort 2
SAD dose 2
干预措施: ASC30 (Drug)
SAD Cohort 2
SAD dose 2
干预措施: Placebo (Other)
SAD Cohort 3
SAD dose 3
干预措施: ASC30 (Drug)
SAD Cohort 3
SAD dose 3
干预措施: Placebo (Other)
SAD Cohort 4
SAD dose 4
干预措施: ASC30 (Drug)
SAD Cohort 4
SAD dose 4
干预措施: Placebo (Other)
SAD Cohort 5
SAD dose 5
干预措施: ASC30 (Drug)
SAD Cohort 5
SAD dose 5
干预措施: Placebo (Other)
MAD Cohort 1
MAD dose 1
干预措施: ASC30 (Drug)
MAD Cohort 1
MAD dose 1
干预措施: Placebo (Other)
MAD Cohort 2
MAD dose 2
干预措施: ASC30 (Drug)
结局指标
主要结局
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
时间窗: Up to Day 8
A summary of AEs, SAEs and other non-serious adverse events
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)
时间窗: Up to Day 28
A summary of AEs, SAEs and other non-serious adverse events
次要结局
- Cmax of ASC30 (SAD)(Up to Day 8)
- Cmax of ASC30 (MAD)(Up to Day 28)
- Change From Baseline in Body Weight (MAD)(Up to Day 28)