A Study of IBI3032 in Healthy Participants

Fortvita Biologics (USA)Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: IBI3032

Study type: Interventional

Funder types: Industry

Identifiers

NCT07120425

CIBI3032A102

Details and patient eligibility

About

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.

Enrollment: 32 estimated 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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32 participants in 8 patient groups, including a placebo group

Single dose4 of IBI3032 administered orally.

Experimental group

Description:

dose4 IBI3032

Treatment:

Drug: IBI3032

Single dose3 of IBI3032 administered orally.

Experimental group

Description:

dose3 IBI3032

Treatment:

Drug: IBI3032

Single dose4 of placebo administered orally.

Placebo Comparator group

Description:

dose4 placebo

Treatment:

Drug: placebo

Single dose1 of IBI3032 administered orally.

Experimental group

Description:

dose1 IBI3032

Treatment:

Drug: IBI3032

Single dose3 of placebo administered orally.

Placebo Comparator group

Description:

dose3 placebo

Treatment:

Drug: placebo

Single dose1 of placebo administered orally.

Placebo Comparator group

Description:

dose1 placebo

Treatment:

Drug: placebo

Single dose2 of IBI3032 administered orally.

Experimental group

Description:

dose2 IBI3032

Treatment:

Drug: IBI3032

Single dose2 of placebo administered orally.

Placebo Comparator group

Description:

dose2 placebo

Treatment:

Drug: placebo