Bioequivalence Study of BGM0504 Injection

NCT07382908 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BGM0504-BE
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Overweight/Obesity

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  Peak Plasma Concentration (Cmax)

  0 to 672 hours

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

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

  0 to 672 hours

Secondary Outcomes (1)

• Monitor all the adverse event

  29 days

Study Arms (3)

Group A

EXPERIMENTAL

Drug: BGM0504 Injection multi-dose pen

Group B

EXPERIMENTAL

Drug: BGM0504 Injection single-dose pen

Group C

ACTIVE COMPARATOR

Drug: BGM0504 Injection single-dose pen

Interventions

BGM0504 Injection single-dose pen DRUG

5 mg, single subcutaneous injection in the abdominal region

Group B

BGM0504 Injection multi-dose pen DRUG

5 mg, single subcutaneous injection in the abdominal region

Group A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• BrightGene Pharmaceutical Co., Ltd.: collaborator
• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

penclomedine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: December 23, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: February 3, 2026

Record last verified: 2025-09

Locations

CN (1)