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RECRUITING
NCT07382908
PHASE1

Bioequivalence Study of BGM0504 Injection

Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-12-23

Completion Date

2026-02-12

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DRUG

BGM0504 Injection multi-dose pen

5 mg, single subcutaneous injection in the abdominal region

DRUG

BGM0504 Injection single-dose pen

5 mg, single subcutaneous injection in the abdominal region

DRUG

BGM0504 Injection single-dose pen

5 mg, single subcutaneous injection in the abdominal region

Locations (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China