Phase Ib Clinical Study of HDM1005 Injection

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT06637020
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • HDM1005 injection or placebo — DRUG
    Within each cohort, subjects are randomized in a 4:1 ratio to receive either HDM1005 injection or placebo subcutaneously.

Study Details

This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study in overweight or obese subjects to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HDM1005 injection in overweight or obese subjects.

Key Dates

First listed
Oct 15, 2024
Start date
Jun 20, 2024
Status verified
Jul 2024
Primary completion
Dec 27, 2024
Completion
Feb 14, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HDM1005 injection dose level 1
    HDM1005 injection or pleacebo dose level 1 qw subcutaneous injection, 4weeks
  • Experimental: HDM1005 injection dose level 2
    HDM1005 injection or pleacebo dose level 2 qw subcutaneous injection, 4weeks
  • Experimental: HDM1005 injection dose level 3
    HDM1005 injection or pleacebo dose level 3 qw subcutaneous injection, 4weeks
  • Experimental: HDM1005 injection dose level 4
    HDM1005 injection or pleacebo dose level 3 qw subcutaneously administered once weekly, for 2 times; subsequently increased to dose level 4 once weekly for 2 times.

Primary Outcome Measure

The incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Signing informed until day 57 ]

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