A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032 After Multiple Ascending Doses in Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
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 multiple ascending doses of IBI3032 in participants with overweight or obesity. It is a multiple ascending dose 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
- •Healthy male or females, as determined by medical history
- •Have safety laboratory results within normal reference ranges
排除标准
- •Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds
- •Abnormal electrocardiogram (ECG) at screening
- •Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
研究组 & 干预措施
Multiple ascending dose5 of IBI3032 administered orally.
Cohort 5 IBI3032
干预措施: IBI3032 (Drug)
Multiple ascending dose1 of placebo administered orally.
Cohort 1 placebo
干预措施: placebo (Drug)
Multiple ascending dose4 of placebo administered orally.
Cohort 4 placebo
干预措施: placebo (Drug)
Multiple ascending dose3 of IBI3032 administered orally.
Cohort 3 IBI3032
干预措施: IBI3032 (Drug)
Multiple ascending dose4 of IBI3032 administered orally.
Cohort 4 IBI3032
干预措施: IBI3032 (Drug)
Multiple ascending dose2 of IBI3032 administered orally.
Cohort 2 IBI3032
干预措施: IBI3032 (Drug)
Multiple ascending dose3 of placebo administered orally.
Cohort 3 placebo
干预措施: placebo (Drug)
Multiple ascending dose5 of placebo administered orally.
Cohort 5 placebo
干预措施: placebo (Drug)
Multiple ascending dose1 of IBI3032 administered orally.
Cohort 1 IBI3032
干预措施: IBI3032 (Drug)
Multiple ascending dose2 of placebo administered orally.
Cohort 2 placebo
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
时间窗: 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: 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
Number of Participants with adverse events (AEs)
时间窗: 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.
Baseline up to Day 43
次要结局
- Under the Serum Concentration-time Curve (AUC) of IBI3032(Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.)
- maximum concentration (Cmax) of IBI3032(Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.)
- time to maximum concentration (Tmax) of IBI3032(Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.)
- clearance (CL) of IBI3032(Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.)
- apparent volume of distribution (V) of IBI3032(Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.)
- elimination half-life (T1/2) of IBI3032(Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.)