A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of IBI3032 in Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male or females, as determined by medical history
- •Have safety laboratory results within normal reference ranges
Exclusion Criteria
- •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.
Arms & Interventions
Single dose2 of IBI3032 administered orally.
dose2 IBI3032
Intervention: IBI3032 (Drug)
D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally.
D1:Administer after meal D9: Fasted administer
Intervention: 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
Intervention: IBI3032 (Drug)
Single dose1 of placebo administered orally.
dose1 placebo
Intervention: placebo (Drug)
Single dose1 of IBI3032 administered orally.
dose1 IBI3032
Intervention: IBI3032 (Drug)
Single dose4 of placebo administered orally.
dose4 placebo
Intervention: placebo (Drug)
Single dose4 of IBI3032 administered orally.
dose4 IBI3032
Intervention: 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
Intervention: placebo (Drug)
D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally.
D1:Administer after meal D9: Fasted administer
Intervention: placebo (Drug)
Single dose2 of placebo administered orally.
dose2 placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Time Frame: (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 One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
Time Frame: (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 adverse events (AEs)
Time Frame: (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.
Secondary Outcomes
- Under the Serum Concentration-time Curve (AUC) of IBI3032(Predose up to 168 hours postdose)
- 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)
- 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)