NCT07224399

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women

A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.

Conditions

• Healhty
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	BGM1812	Administered SC.
DRUG	Placebo	Administered SC.
DRUG	BGM1812	Administered SC.
DRUG	Placebo	Administered SC.

Timeline

• Start date: 2025-10-09
• Primary completion: 2026-05-15
• Completion: 2026-05-15
• First posted: 2025-11-04
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study