Bioequivalence Study of BGM0504 Injection
ConditionOverweight/Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBrightGene Bio-Medical Technology Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BGM0504 Injection multi-dose pen
- BGM0504 Injection single-dose pen
- BGM0504 Injection single-dose pen
Treatment groups
144 Participants
are divided into 3 treatment groupsSponsors and collaborators
BrightGene Bio-Medical Technology Co., Ltd.
Lead sponsor
BrightGene Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov