Actively Recruiting
Phase 1 Study of Single Dose IBIO-600 Injection to Evaluate Safety and Effects in Overweight or Obese Adults Aged 18 to 65
Led by iBio, Inc. · Updated on 2026-05-29
32
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the effects of a drug called IBIO-600 in adults who are overweight or obese. The goal is to find the best dose that balances safety, tolerability, and impact on body composition. This Phase 1, first-in-human, randomized, double-blind, placebo-controlled study also examines how the drug moves through and affects the body and how the immune system responds. Participants receive a single subcutaneous injection of either IBIO-600 at different dose levels or a matching placebo. The study involves ascending doses given to separate groups to evaluate safety and drug behavior. Participants are monitored for 9 months after the dose to assess effects on body composition and physical function. During the study, participants undergo various assessments including safety and tolerability checks, blood tests to measure drug levels and immune response, and evaluations of body composition and physical activity. Safety is monitored from the first day until the end of the study at 252 days. The trial lasts about 9 months, during which researchers carefully track how the drug affects participants and any side effects that occur.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults
Research Team
C
Cory Schwartz, PhD
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