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.
Aged 18 to 65 years of age
In good general health, with no significant medical history
BMI between ≥ 27.0 and ≤ 34.90 kg/m2
History of self-reported stable body weight (defined as change of no more or less than ± 5%) within 90 days of Screening.
An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.
History or active diagnosis of diabetes (Type 1 or 2).
History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months).
History or presence of clinically significant muscle disease
Sequential
IBIO-600
DrugIBIO-600 Subcutaneous injection
Placebo
DrugMatching placebo; subcutaneous injection
Assessment of the safety and tolerability of a single dose of IBIO-600
Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs.
Pharmacokinetics of a single dose of IBIO-600
Maximum observed serum concentration (Cmax)
Pharmacokinetics of a single dose of IBIO-600
Time to maximum concentration (Tmax)
Pharmacokinetics of a single dose of IBIO-600
Area under the curve (AUC)
Pharmacokinetics of a single dose of IBIO-600
AUC
