A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032 After a Single Ascending Dose in Healthy Participants and After Multiple Ascending Doses in Participants With Overweight or Obesity

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a randomized, double-blind, placebo-controlled phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single ascending dose of IBI3032 in healthy participants and multiple ascending doses of IBI3032 in participants with overweight or obesity. It consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy participants, and Part B is a multiple ascending dose (MAD) study in participants with overweight or obesity during the 4-week treatment period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Male or female aged 18-65 years (inclusive) at the time of informed consent.

• Participants must understand the procedures and methods of this study, be willing to complete the study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.

Locations
Other Locations
China
Zhongshan Hospital affiliated to Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Dee Li
dee.li@innoventbio.com
18017984650
Time Frame
Start Date: 2025-08-27
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 92
Treatments
Experimental: Single dose of IBI3032 administered orally.
Part A
Placebo_comparator: Single dose of placebo administered orally.
Part A
Experimental: Multiple doses of IBI3032 administered orally.
Part B
Placebo_comparator: Multiple doses of placebo administered orally.
Part B
Related Therapeutic Areas
Sponsors
Leads: Innovent Biologics Technology Limited (Shanghai R&D Center)

This content was sourced from clinicaltrials.gov

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