A Study of IBI3032 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2025-11-13

Brief Summary

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This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, and PK of a single dose of IBI3032 in healthy participants. This is a single ascending dose (SAD) study. Approximately 32 healthy participants are expected to be enrolled in this study.

The screening period is 4 weeks. Eligible participants will be divided into 4 cohorts. Each cohort 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. This study is for research purposes only, and is not intended to treat any medical condition.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single dose4 of IBI3032 administered orally.

dose4 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032:

Method of administration: oral, fasted administration.

Single dose3 of IBI3032 administered orally.

dose3 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032:

Method of administration: oral, fasted administration.

Single dose4 of placebo administered orally.

dose4 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo (without active ingredients) Method of administration: oral, fasted administration.

Single dose1 of IBI3032 administered orally.

dose1 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032:

Method of administration: oral, fasted administration.

Single dose3 of placebo administered orally.

dose3 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo (without active ingredients) Method of administration: oral, fasted administration.

Single dose1 of placebo administered orally.

dose1 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo (without active ingredients) Method of administration: oral, fasted administration.

Single dose2 of IBI3032 administered orally.

dose2 IBI3032

Group Type EXPERIMENTAL

IBI3032

Intervention Type DRUG

IBI3032:

Method of administration: oral, fasted administration.

Single dose2 of placebo administered orally.

dose2 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo (without active ingredients) Method of administration: oral, fasted administration.

Interventions

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IBI3032

IBI3032:

Method of administration: oral, fasted administration.

Intervention Type DRUG

placebo

Placebo (without active ingredients) Method of administration: oral, fasted administration.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes