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Bioequivalence Study of BGM0504 Injection

NCT07382908 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-02-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • BrightGene Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • BrightGene Bio-Medical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-23
Primary Completion
2026-02-12
Completion
2026-02-12
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07382908 on ClinicalTrials.gov