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Completed

NCT Number: NCT07134127

A Study of IBI3032 in Chinese Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The Frist Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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.

IBI3032

Drug

IBI3032: (cohort1, 2,4) Method of administration: oral, fasted administration. IBI3032: (cohort3) Method of administration: oral, administration after meal.

Primary outcomes

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

    Time frame: (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

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

    Time frame: (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

  3. Number of Participants with adverse events (AEs)

    Time frame: (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 outcomes

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

    Time frame: Predose up to 168 hours postdose

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

  2. maximum concentration (Cmax) of IBI3032

    Time frame: Predose up to 168 hours postdose

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

  3. time to maximum concentration (Tmax) of IBI3032

    Time frame: Predose up to 168 hours postdose

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

  4. clearance (CL) of IBI3032

    Time frame: Predose up to 168 hours postdose

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

  5. apparent volume of distribution (V) of IBI3032

    Time frame: Predose up to 168 hours postdose

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

  6. elimination half-life (T1/2) of IBI3032

    Time frame: Predose up to 168 hours postdose

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

Sponsors and collaborators

Lead sponsor

Innovent Biologics Technology Limited (Shanghai R&D Center)

Industry

Registry information

Official study title

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of IBI3032 in Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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