Bioequivalence Study of BGM0504 Injection in Overweight and Obese Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the bioequivalence of different formulations of BGM0504 Injection in adults who are overweight or obese. This Phase 1 study compares a multi-dose pen and a single-dose pen of BGM0504 experimental formulas T1 and T2 with a single-dose pen of BGM0504 reference formula R. The goal is to understand how these forms of the drug behave in the body after a single injection. Participants will receive a single subcutaneous injection of 5 mg BGM0504 in the abdominal region using one of the study pens. The study is randomized, open-label, and parallel in design, meaning participants are assigned to one of three groups receiving different formulations for comparison. There is only one treatment period where the injection is given. Participants will be monitored for up to 672 hours after dosing to measure peak plasma concentration and the total drug exposure over time. Safety will be assessed by tracking any adverse events for 29 days following dosing. Participants must attend scheduled visits for blood sampling and evaluations to help researchers compare how the drug is absorbed and processed. The study lasts about one month from dosing through safety follow-up.

Bioequivalence Study of BGM0504 Injection