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Phase 1 Study to Assess Safety, Tolerability, and Pharmacokinetics of BGM1812 Injection in Healthy, Non-Diabetic Overweight or Obese Chinese Adults
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-12-19
60
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and how the body processes a drug called BGM1812 when given by injection under the skin in healthy, non-diabetic Chinese adults who are overweight or obese. This Phase 1 study aims to understand the drugs effects on the body and how it moves through the bloodstream. Participants include men and women aged 18 to 55 years with specific body weight and body mass index BMI ranges. The study includes groups receiving single and multiple increasing doses of BGM1812 by subcutaneous injection, as well as matching placebo injections. Participants are randomly assigned to receive either the drug or placebo in a double-blind manner, meaning neither participants nor researchers know which treatment is given. The trial investigates safety, tolerability, pharmacokinetics, and pharmacodynamics over a period of up to 6 to 9 weeks. During the study, participants will be monitored for any adverse events and will have various assessments including blood tests to measure drug levels and effects on fasting blood glucose, insulin, C-peptide, body weight, and waist circumference. Immunogenicity tests will also be performed. Participants must follow study schedules and restrictions, with safety and tolerability data collected from baseline through study completion.
CONDITIONS
Brief Title
A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants
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