A Study of IBI3032 in Chinese Healthy Subjects

Early Phase 1CompletedNCT07134127

Innovent Biologics Technology Limited (Shanghai R&D Center)40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Time frame: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15

Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time frame: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15

Number of Participants with adverse events (AEs)

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.

Time frame: (Cohoet1,2,4) Baseline up to Day 15 (Cohoet3) Baseline up to Day 15

Secondary Outcomes

Under the Serum Concentration-time Curve (AUC) of IBI3032

To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.