NCT06985615

A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement

A Multi-center, Parallel Cohort, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HDM1002 in Subjects With Normal Hepatic Function and Hepatic Impairment.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002

Conditions

• Hepatic Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Single dose of HDM1002 on Day 1	Single dose of HDM1002 will be administered on Day 1

Timeline

• Start date: 2025-03-18
• Primary completion: 2026-01-14
• Completion: 2026-05-14
• First posted: 2025-05-22
• Last updated: 2025-05-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study