Bioequivalence Study of BGM0504 Injection

NCT07382908
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
144
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Lead sponsor
BrightGene Bio-Medical Technology Co., Ltd.
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Start date
2025-12-23
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Number of sites
1
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Summary
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).
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Short title
Bioequivalence Study of BGM0504 Injection
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Official title
A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-02-12
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First posted
2026-02-03
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Registry last updated
2026-02-03
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Primary completion date
2026-02-12
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Start date
2025-12-23
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Participants
144
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Participant count basis
Estimated
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Planned participants
144
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Protocol amendments
0
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
BrightGene Bio-Medical Technology Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07382908
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ClinicalTrials.gov ID
NCT07382908
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Peak Plasma Concentration (Cmax)

    Timeframe: 0 to 672 hours

    Peak Plasma Concentration (Cmax)

  2. Area under the plasma concentration versus time curve (AUC)0-t

    Timeframe: 0 to 672 hours

    Area under the plasma concentration versus time curve (AUC)0-t

  1. Monitor all the adverse event

    Timeframe: 29 days

    Monitor all the adverse event was assessed by the investigator.

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No

  • 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.

  • 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..
Sources for eligibility
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  • Hangzhou First People's HospitalHangzhou, ChinaRecruiting
Sources for sites
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Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)