A Study of IBI3032 in Chinese Healthy Subjects

Innovent Biologics Technology Limited (Shanghai R&D Center)

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: IBI3032

Study type: Interventional

Funder types: Industry

Identifiers

NCT07134127

CIBI3032T001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 10 patient groups, including a placebo group

Single dose1 of IBI3032 administered orally.

Experimental group

Description:

dose1 IBI3032

Treatment:

Drug: IBI3032

Single dose4 of placebo administered orally.

Placebo Comparator group

Description:

dose4 placebo

Treatment:

Drug: placebo

Single dose4 of IBI3032 administered orally.

Experimental group

Description:

dose4 IBI3032

Treatment:

Drug: IBI3032

D1:Single dose3-1 of placebo administered orally. D9:Single dose3-1 of placebo administered orally.

Active Comparator group

Description:

D1: Fasted administer D9:Administer after meal

Treatment:

Drug: placebo

Single dose2 of IBI3032 administered orally.

Experimental group

Description:

dose2 IBI3032

Treatment:

Drug: IBI3032

D1:Single dose3-2 of placebo administered orally. D9:Single dose3-2 of placebo administered orally.

Active Comparator group

Description:

D1:Administer after meal D9: Fasted administer

Treatment:

Drug: placebo

D1:Single dose3-2 of IBI3032 administered orally. D9:Single dose3-2 of IBI3032 administered orally.

Experimental group

Description:

D1:Administer after meal D9: Fasted administer

Treatment:

Drug: IBI3032

D1:Single dose3-1 of IBI3032 administered orally. D9:Single dose3-1 of IBI3032 administered orally.

Experimental group

Description:

D1: Fasted administer D9:Administer after meal

Treatment:

Drug: IBI3032

Single dose1 of placebo administered orally.

Placebo Comparator group

Description:

dose1 placebo

Treatment:

Drug: placebo

Single dose2 of placebo administered orally.

Placebo Comparator group

Description:

dose2 placebo

Treatment:

Drug: placebo