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COMPLETED
NCT06637020
PHASE1

Phase Ib Clinical Study of HDM1005 Injection

Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous (SC) Doses of HDM1005 Injection in Overweight or Obese Subjects

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-06-21

Completion Date

2025-06-24

Last Updated

2026-08-24

Healthy Volunteers

Yes

Interventions

DRUG

HDM1005 injection or placebo

In Part 1, within each cohort, subjects are randomized in a 4:1 ratio to receive either HDM1005 injection or placebo subcutaneously.

DRUG

HDM1005 injection or placebo

In Part 2,subjects are randomized in a 3:1 ratio to receive either HDM1005 injection or placebo subcutaneously.

Locations (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China