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Recruiting NCT07120425

A Study of IBI3032 in Healthy Participants

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI3032, placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug IBI3032
    IBI3032: Method of administration: oral, fasted administration.
  • Drug placebo
    Placebo (without active ingredients) Method of administration: oral, fasted administration.

Primary outcome measures

  • Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug [Time frame: 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 [Time frame: Baseline up to Day 15]
  • Number of Participants with adverse events (AEs) [Time frame: Baseline up to Day 15]
Secondary outcome measures (6)
  • Under the Serum Concentration-time Curve (AUC) of IBI3032 [Time frame: Predose up to 168 hours postdose]
  • maximum concentration (Cmax) of IBI3032 [Time frame: Predose up to 168 hours postdose]
  • time to maximum concentration (Tmax) of IBI3032 [Time frame: Predose up to 168 hours postdose]
  • clearance (CL) of IBI3032 [Time frame: Predose up to 168 hours postdose]
  • apparent volume of distribution (V) of IBI3032 [Time frame: Predose up to 168 hours postdose]
  • elimination half-life (T1/2) of IBI3032 [Time frame: Predose up to 168 hours postdose]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • ICON Clinical Research — Lenexa

Identifiers

NCT: NCT07120425 · CIBI3032A102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗