A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032 After a Single Ascending Dose in Healthy Participants and After Multiple Ascending Doses in Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Participants with adverse events (AEs)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single ascending dose of IBI3032 in healthy participants and multiple ascending doses of IBI3032 in participants with overweight or obesity. It consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy participants, and Part B is a multiple ascending dose (MAD) study in participants with overweight or obesity during the 4-week treatment period.
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
- Double (Participant, Investigator)
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
- •Male or female aged 18-65 years (inclusive) at the time of informed consent.
- •Participants must understand the procedures and methods of this study, be willing to complete the study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.
排除标准
- •The investigator suspects that the participant may be allergic to any component of the study drug or GLP-1 receptor agonists, or have used GLP-1 receptor agonists within 3 months prior to screening.
- •History of diabetes, or HbA1c ≥ 6.5% and fasting blood glucose < 3.9 mmol/L or ≥ 7.0 mmol/Lat screening.
- •Presence of any other abnormalities in vital signs and laboratory tests that are clinically significant as judged by the investigator at screening.
研究组 & 干预措施
Single dose of IBI3032 administered orally.
Part A
干预措施: IBI3032 tablets (Drug)
Single dose of placebo administered orally.
Part A
干预措施: Placebo (Drug)
Multiple doses of IBI3032 administered orally.
Part B
干预措施: IBI3032 tablets (Drug)
Multiple doses of placebo administered orally.
Part B
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with adverse events (AEs)
时间窗: Part A: Baseline up to Day 15
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
时间窗: Part A: Baseline up to Day 15
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
时间窗: Part A: Baseline up to Day 15
A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Number of Participants with adverse events (AEs)
时间窗: Part B: Baseline up to Day 43
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
时间窗: Part B: Baseline up to Day 43
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
时间窗: Part B: Baseline up to Day 43
A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
次要结局
- Under the Serum Concentration-time Curve (AUC) of IBI3032(Part A: Predose up to 168 hours postdose)
- maximum concentration (Cmax) of IBI3032(Part A: Predose up to 168 hours postdose)
- time to maximum concentration (Tmax) of IBI3032(Part A: Predose up to 168 hours postdose)
- clearance (CL) of IBI3032(Part A: Predose up to 168 hours postdose)
- apparent volume of distribution (V) of IBI3032(Part A: Predose up to 168 hours postdose)
- elimination half-life (T1/2) of IBI3032(Part A: Predose up to 168 hours postdose)
- Under the Serum Concentration-time Curve (AUC) of IBI3032(Part B: Predose up to 168 hours postdose)
- maximum concentration (Cmax) of IBI3032(Part B: Predose up to 168 hours postdose)
- time to maximum concentration (Tmax) of IBI3032(Part B: Predose up to 168 hours postdose)
- clearance (CL) of IBI3032(Part B: Predose up to 168 hours postdose)
- apparent volume of distribution (V) of IBI3032(Part B: Predose up to 168 hours postdose)
- elimination half-life (T1/2) of IBI3032(Part B: Predose up to 168 hours postdose)