Actively Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-12-19
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
BrightGene Bio-Medical Technology Co., Ltd.
Lead Sponsor
B
BrightGene Pharmaceutical Co., Ltd.
Collaborating Sponsor
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 drug's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years old at screening
- Healthy and non-diabetic overweight or obese individuals
- Male weight at least 50 kg, female weight at least 45 kg
- Body mass index (BMI) between 20.0 and less than 24.0 kg/m² for healthy subjects
- BMI 28.0 kg/m² or higher for obese, or BMI between 24.0 and less than 28.0 kg/m² for overweight
- Stable body weight with less than 5% change in the past 12 weeks
- No history of mental disorders and able to communicate and understand consent
- Male participants with female partners of reproductive potential must agree to use contraception and refrain from sperm donation during and for 3 months after the study
You will not qualify if you...
- History of severe drug allergies or severe allergic diseases
- Positive for HBsAg, anti-HCV, anti-HIV, or anti-TP at screening
- Abnormal heart rhythm or significant arrhythmias on ECG
- Illegal drug use within 6 months or substance abuse within 12 months before screening
- Participation in drug or device trials with active treatment within 12 weeks before screening
- Receipt of any vaccine within 2 weeks before screening or planned vaccination during the trial
- Pregnancy, lactation, or positive pregnancy test during screening
- Positive urine drug or alcohol serum test at screening or baseline
- Other conditions deemed unsuitable by the Investigator
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 visit (in-person)
Duration - Up to 6 to 9 weeks
Participants receive single or multiple ascending doses of BGM1812 or placebo administered subcutaneously to evaluate tolerability, safety, and pharmacokinetics.
Multiple dosing visits during treatment period
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Yunnan University of Chinese Medicine
Kunming, Yunnan, China, 650000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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