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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Study ID
NCT07224399
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healhty
  • Overweight or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BGM1812 — DRUG
    Administered SC.
  • Placebo — DRUG
    Administered SC.
  • BGM1812 — DRUG
    Administered SC.
  • Placebo — DRUG
    Administered SC.

Study Details

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.

Key Dates

Start date
Oct 9, 2025
Status verified
Aug 2025
Primary completion
May 15, 2026
Completion
May 15, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BGM1812 (Part A)
    Single ascending doses of BGM1812 administered subcutaneously (SC).
  • Placebo Comparator: Placebo (Part A)
    Placebo administered SC.
  • Experimental: BGM1812 (Part B)
    Multiple ascending doses of BGM1812 administered SC.
  • Placebo Comparator: Placebo (Part B)
    Placebo administered SC.

Primary Outcome Measure

Number of treatment adverse events [ Time Frame: Predose up to 6 weeks (Part A) & 9 weeks (Part B) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pharmaron CPC, IncBaltimoreMaryland21201
MD, MPH, FACP
[email protected]
410-706-8877

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By research site
Pharmaron CPC, Inc· Baltimore, MD

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