Phase Ia Clinical Study of HDM1005 Injection

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT06640647
Phase
PHASE1
Status
Completed

Conditions

  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase Ia clinical study. It is aimed to evaluate the safety, tolerability, PK and PD characteristics of HDM1005 injection in healthy adult subjects.

Key Dates

First listed
Oct 15, 2024
Start date
Mar 19, 2024
Status verified
Oct 2024
Primary completion
Aug 6, 2024
Completion
Sep 26, 2024

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HDM1005 injection dose level 1
    HDM1005 injection or placebo dose level 1 once subcutaneous injection
  • Experimental: HDM1005 injection dose level 2
    HDM1005 injection or placebo dose level 2 once subcutaneous injection
  • Experimental: HDM1005 injection dose level 3
    HDM1005 injection or placebo dose level 3 once subcutaneous injection
  • Experimental: HDM1005 injection dose level 4
    HDM1005 injection or placebo dose level 4 once subcutaneous injection
  • Experimental: HDM1005 injection dose level 5
    HDM1005 injection or placebo dose level 5 once subcutaneous injection
  • Experimental: HDM1005 injection dose level 6
    HDM1005 injection or placebo dose level 6 once subcutaneous injection
  • Experimental: HDM1005 injection dose level 7
    HDM1005 injection or placebo dose level 7 once subcutaneous injection

Primary Outcome Measure

Safety Outcomes [ Time Frame: Signing informed until day 29 ]

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