A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of IBI3032 in Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 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 I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 40 healthy participants are expected to be enrolled in this study. The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Cohort1,2,4 consisted of 8 healthy participants who will be randomized in a 6:2 ratio to receive a single dose of IBI3032 or placebo. The safety follow-up period is 15 days. Cohort 3 consisted of 16 participants used a two-cycle, double-crossover design, who were randomly divided into four groups at a ratio of 3:1:3:1: Cohort 3-1-IBI3032, cohort 3-1-placebo, cohort 3-2-IBI3032, and cohort 3-2-placebo, each subject underwent two cycles of the trial. In cohort 3-1, the first cycle was given on fasted administration, and the second cycle was given after breakfast. In cohort 3-2, the first cycle was administered after breakfast intake, and the second cycle was administered fasted. The washout period for cohort 3-1 and cohort 3-2 was 8 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
Single dose1 of IBI3032 administered orally.
dose1 IBI3032
干预措施: IBI3032 (Drug)
Single dose4 of placebo administered orally.
dose4 placebo
干预措施: placebo (Drug)
Single dose4 of IBI3032 administered orally.
dose4 IBI3032
干预措施: IBI3032 (Drug)
D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally.
D1: Fasted administer D9:Administer after meal
干预措施: placebo (Drug)
Single dose2 of IBI3032 administered orally.
dose2 IBI3032
干预措施: IBI3032 (Drug)
D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally.
D1:Administer after meal D9: Fasted administer
干预措施: placebo (Drug)
D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally.
D1:Administer after meal D9: Fasted administer
干预措施: IBI3032 (Drug)
D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally.
D1: Fasted administer D9:Administer after meal
干预措施: IBI3032 (Drug)
Single dose1 of placebo administered orally.
dose1 placebo
干预措施: placebo (Drug)
Single dose2 of placebo administered orally.
dose2 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: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) 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: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) 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: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) 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.
次要结局
- apparent volume of distribution (V) of IBI3032(Predose up to 168 hours postdose)
- elimination half-life (T1/2) of IBI3032(Predose up to 168 hours postdose)
- Under the Serum Concentration-time Curve (AUC) of IBI3032(Predose up to 168 hours postdose)
- maximum concentration (Cmax) of IBI3032(Predose up to 168 hours postdose)
- time to maximum concentration (Tmax) of IBI3032(Predose up to 168 hours postdose)
- clearance (CL) of IBI3032(Predose up to 168 hours postdose)