NCT07487376

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults

A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBIO-600 in Overweight or Obese Adult Participants (IBIO-600-CT001).

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: iBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.

Detailed description

The study is a single ascending dose study, with participants monitored for 9 months after administration. This clinical trial will seek to address the following: * Which dose of the study drug is most effective. * How safe the study drug is and how well participants tolerate it. * How much of the study drug can be found in blood (pharmacokinetics). * How the study drug affects the body (pharmacodynamics). * How the body's immune system responds to the study drug (immunogenicity). * How the body's composition and physical function may change over the course of the study.

Conditions

• Overweight , Obesity

Interventions

Type	Name	Description
DRUG	IBIO-600	IBIO-600 Subcutaneous injection
DRUG	Placebo	Matching placebo; subcutaneous injection

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Australia