Actively Recruiting
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBIO-600 in Overweight or Obese Adults
Led by iBio, Inc. · Updated on 2026-05-29
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years of age
- In good general health, with no significant medical history
- Body mass index (BMI) between 27.0 and 34.90 kg/m2
- Stable body weight (change within ±5%) within 90 days of screening
- Willing to avoid reconstructive or cosmetic procedures affecting body weight during the study
- Fully ambulatory without chronic orthopedic diseases or use of mobility aids
- Nonsmoker/nonvaper with no nicotine or synthetic product use in the month before randomization
- Not pregnant or breastfeeding
- Women of childbearing potential or fertile men must agree to use contraception from screening until 9 months after last dose
You will not qualify if you...
- Physical or psychological conditions that may prevent study compliance or completion
- History or active diagnosis of type 1 or type 2 diabetes
- History of insulinoma or recurrent hypoglycemia (≥3 episodes in past 3 months)
- Clinically significant muscle disease
- History or active cardiovascular disease including arrhythmias, heart failure, coronary artery disease, thromboembolism, or pulmonary hypertension
- Significant laboratory abnormalities preventing participation
- History of malignancy except certain treated skin or cervical conditions
- Conditions causing significant immunosuppression
- History of substance abuse, dependency, or recreational intravenous drug use in past 5 years (self-reported)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single dose with monitoring through 9 months
Participants receive a single subcutaneous injection of IBIO-600 or placebo and are monitored for safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity.
Multiple visits over 9 months for assessments
Trial Site Locations
Total: 1 location
1
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
Research Team
C
Cory Schwartz, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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