Bioequivalence Study of BGM0504 Injection

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Overweight/Obesity

Treatments: Drug: BGM0504 Injection multi-dose pen; Drug: BGM0504 Injection single-dose pen

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07382908

BGM0504-BE

Details and patient eligibility

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).

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-55 years (inclusive).
• Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).
• From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.
• The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.

Exclusion criteria

• History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.
• Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
• Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.
• History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
• Past or screening findings of digestive system diseases that may increase participant risk.
• Positive for HBsAg, HCV antibody, syphilis antibody, or HIV antibody at screening.
• Participation in any drug or medical device clinical trial and receiving investigational product/device intervention within 3 months prior to screening.
• Consumption or plan to consume specific foods (including pitaya, mango, grapefruit, pomelo or their juices, high-purine foods like animal organs, seafood, chocolate) or beverages containing caffeine/alcohol within 48 hours before dosing; or unwilling to stop consuming these during the in-house period.
• Pregnant or breastfeeding women, or positive pregnancy test at screening.
• Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 3 patient groups

Group A

Experimental group

Treatment:

Drug: BGM0504 Injection multi-dose pen

Group B

Experimental group

Treatment:

Drug: BGM0504 Injection single-dose pen

Drug: BGM0504 Injection single-dose pen

Group C

Active Comparator group

Treatment:

Drug: BGM0504 Injection single-dose pen

Drug: BGM0504 Injection single-dose pen