NCT06637020

Phase Ib Clinical Study of HDM1005 Injection

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is designed to consist of 5 dose cohorts, with 10 subjects in each cohort. Within each cohort, subjects are randomized in a 4:1 ratio to receive either HDM1005 injection or placebo subcutaneously. The proposed dose cohorts are as follows: cohort a (0.5 mg), cohort b (1.0 mg), cohort c (2.0 mg), cohort d (4.0 mg), cohort e (8.0 mg). Cohorts d,e will use a titration method to gradually reach the target dose. After obtaining safety and tolerability data for at least 14 days following multiple ascending dose (MAD) in the previous dose cohort, the dose to be administered and titration strategy for the next dose cohort are jointly determined by the investigator and the sponsor. Administration is allowed in the higher dose cohort only if the data from the lower dose cohort is indicative of safety. If necessary, the sponsor may continue to explore higher dose cohorts with the agreement of both the investigator and the sponsor.

Conditions

• Overweight and Obesity

Interventions

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

Timeline

• Start date: 2024-06-20
• Primary completion: 2024-12-27
• Completion: 2025-02-14
• First posted: 2024-10-15
• Last updated: 2025-12-16

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study