Actively Recruiting
Bioequivalence Study of BGM0504 Injection in Overweight and Obese Adults Using Single and Multi-Dose Pens
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2026-02-03
144
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 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.
CONDITIONS
Brief 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, female participants weighing at least 45 kg
- Participants must be overweight (BMI between 24.0 and less than 28.0 kg/m²) or obese (BMI of 28.0 kg/m² or higher)
- Willing to avoid pregnancy or causing pregnancy from signing informed consent until 3 months after dosing, and agree to use effective contraception during this period
- Understand the trial purpose, procedures, and possible side effects, and able to comply with the study protocol
- Good communication with the investigator and voluntarily sign the informed consent form
You will not qualify if you...
- History of severe allergies or allergic diseases such as asthma, urticaria, eczematous dermatitis, or allergic to two or more foods or drugs
- Known or suspected allergy to any component 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 or risk factors for pancreatitis, including acute or chronic pancreatitis or pancreatic injury
- Digestive system diseases that increase participant risk
- Positive test for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antibody at screening
- Participation in other drug or medical device trials with investigational products within 3 months prior to screening
- Consumption or planned consumption of certain foods or beverages like pitaya, mango, grapefruit, pomelo, high-purine foods, caffeine, or alcohol within 48 hours before dosing
- Pregnant or breastfeeding women, or positive pregnancy test at screening
- Any other condition deemed unsuitable by the investigator or reasons for participant withdrawal
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 672 hours (28 days)
Participants receive a single subcutaneous injection of the study drug using either a single-dose or multi-dose pen.
1 dosing visit and multiple follow-up visits for up to 28 days
Duration - 29 days
Participants are monitored for adverse events and safety for 29 days after dosing.
Approximately 3 to 4 post-dosing visits
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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