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Recruiting Phase 1 NCT06985615

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

Trial Parameters

Condition Hepatic Impairment
Sponsor Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-03-18
Completion 2026-01-14
Interventions
Single dose of HDM1002 on Day 1

Brief 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

Eligibility Criteria

Inclusion Criteria: 1. Age and Sex: Chinese subjects aged 18-70 years (inclusive) at screening, regardless of gender. The normal hepatic function group and hepatic impairment group must be age-matched within ±10 years, with gender matching as close as possible (±1 subject per gender). 2. Body Weight and Body Mass Index (BMI): At screening, male subjects must weigh ≥50.0 kg, and female subjects ≥40.0 kg, with a BMI ranging from 19.0 to 32.0 kg/m² (inclusive).The normal hepatic function group and hepatic impairment group must be weight-matched within ±10 kg. Exclusion Criteria: 1. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; or serum calcitonin ≥50 ng/L at screening. 2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to signing the informed consent form (ICF). 3. History of acute gallbladder disease within 3 months prior to signing the ICF. 4. History of Malignancy:

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