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Phase 1
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID06985615

Study of HDM1002 Drug Effects in Adults With and Without Liver Problems Aged 18 to 70

Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-05-22

40

Participants Needed

1

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of liver function impairment on how the drug HDM1002 behaves in the blood. The study focuses on adults aged 18 to 70, including those with normal liver function and varying degrees of liver impairment. This Phase 1 trial aims to understand the drugs pharmacokinetics, safety, and tolerability in these different groups. Participants receive a single dose of HDM1002 on the first day of the study. The study includes separate groups for people without hepatic impairment and those with mild, moderate, or severe hepatic impairment. Researchers compare how the drug is processed in the body across these groups. During the trial, blood samples will be collected at multiple time points up to 72 hours after dosing to measure drug concentration and binding in plasma. Safety and tolerability are monitored throughout. The study is randomized and open-label, with participation lasting through the sampling period. The trial is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

CONDITIONS

Brief Title

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

Research Team

L

Liyan Miao

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