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NCT Number: NCT07382908

Bioequivalence Study of BGM0504 Injection

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location status: Recruiting

Location contact

Ying Wang

CONTACT

[email protected]

8618367124548

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

BGM0504 Injection multi-dose pen

Drug

5 mg, single subcutaneous injection in the abdominal region

BGM0504 Injection single-dose pen

Drug

5 mg, single subcutaneous injection in the abdominal region

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 0 to 672 hours

    Peak Plasma Concentration (Cmax)

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

    Time frame: 0 to 672 hours

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

Secondary outcomes

  1. Monitor all the adverse event

    Time frame: 29 days

    Monitor all the adverse event was assessed by the investigator.

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Collaborators

  • BrightGene Pharmaceutical Co., Ltd.

Registry information

Official study title

A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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