Healthy
Conditions
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.
Interventions
DRUGplacebo
Placebo (without active ingredients) (cohort1, 2,4) Method of administration: oral, fasted administration. Placebo (without active ingredients) (cohort3) Method of administration: oral, administration after meal.
DRUGIBI3032
IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.
Sponsors
Innovent Biologics Technology Limited (Shanghai R&D Center)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug | (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 | (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) | (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
| Measure | Time frame | Description |
|---|---|---|
| clearance (CL) of IBI3032 | Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| Under the Serum Concentration-time Curve (AUC) of IBI3032 | Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| elimination half-life (T1/2) of IBI3032 | Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| apparent volume of distribution (V) of IBI3032 | Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| maximum concentration (Cmax) of IBI3032 | Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
| time to maximum concentration (Tmax) of IBI3032 | Predose up to 168 hours postdose | To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants. |
Countries
China
Outcome results
None listed