Actively Recruiting
Bioequivalence Study of BGM0504 Injection
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2026-02-03
144
Participants Needed
1
Research Sites
7 weeks
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
This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).
CONDITIONS
Official Title
Bioequivalence Study of BGM0504 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years (inclusive)
- Male participants weighing at least 50 kg or female participants weighing at least 45 kg
- Overweight (BMI 24.0 to less than 28.0 kg/m²) or obese (BMI 28.0 kg/m² or higher)
- Willing to avoid pregnancy and use effective contraception from signing consent until 3 months after dosing
- Understands the study purpose, can follow the trial protocol, maintains good communication with investigators, and voluntarily signs informed consent
You will not qualify if you...
- History of severe allergies or allergic diseases such as asthma, urticaria, or eczematous dermatitis
- Allergic to two or more foods or drugs or any ingredient of BGM0504 Injection
- Previous diagnosis of type 1 or type 2 diabetes or abnormal HbA1c at screening
- Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome
- History of acute or chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis
- Digestive system diseases that may increase risk
- Positive test for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antibody at screening
- Participation in any drug or device trial with investigational intervention within 3 months prior to screening
- Consumption or planned consumption of certain foods or beverages containing caffeine or alcohol within 48 hours before dosing or unwillingness to stop during the in-house period
- Pregnant or breastfeeding women or positive pregnancy test at screening
- Any condition deemed unsuitable by the investigator or participant withdrawal due to personal reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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