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

NCT ID: NCT06985615

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2026-05-14

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

Conditions

Hepatic Impairment; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects Without Hepatic Impairment

Group Type: EXPERIMENTAL

Single dose of HDM1002 on Day 1

Intervention Type: DRUG

Single dose of HDM1002 will be administered on Day 1

Subjects With Mild Hepatic Impairment

Group Type: EXPERIMENTAL

Single dose of HDM1002 on Day 1

Intervention Type: DRUG

Single dose of HDM1002 will be administered on Day 1

Subjects With Moderate Hepatic Impairment

Group Type: EXPERIMENTAL

Single dose of HDM1002 on Day 1

Intervention Type: DRUG

Single dose of HDM1002 will be administered on Day 1

Subjects With Severe Hepatic Impairment

Group Type: EXPERIMENTAL

Single dose of HDM1002 on Day 1

Intervention Type: DRUG

Single dose of HDM1002 will be administered on Day 1

Interventions

Single dose of HDM1002 on Day 1

Single dose of HDM1002 will be administered on Day 1

Intervention Type: DRUG

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: Diagnosis of any malignancy within 5 years prior to ICF signing (except basal cell carcinoma treated with curative intent and deemed cured).

5. Severe Systemic Diseases: History of severe cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, or other systemic diseases (e.g., acute myocardial infarction, severe depression, gastric ulcer, uremia) within 1 year prior to ICF signing.

6. Conditions Affecting Drug Pharmacokinetics: Presence of dysphagia or any condition that, on the investigator's judgment, may impact drug absorption, distribution, metabolism, or excretion (e.g., active inflammatory bowel disease, gastrectomy, intestinal resection) at screening.

7. Severe Hypoglycemia: Episode of severe hypoglycemia within 3 months prior to screening.

8. Allergy or Intolerance: History of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis) or known intolerance/allergy to glucagon-like peptide-1 receptor (GLP-1R) agonists.

9. Hepatic Function Normal Group Exclusions:a) History of chronic liver disease, including hepatitis, hepatitis B, or hepatitis C, or positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV) at screening.b) Positive Treponema pallidum antibody.c) Use of any medication within 28 days or 5 elimination half-lives (whichever is longer) prior to the first study drug administration.

10. Hepatic Impairment Group Exclusions:a) Hepatocellular carcinoma, hepatorenal syndrome, or limited life expectancy (defined as <1 year for the hepatic impairment cohort).b) Cirrhosis complications (e.g., gastrointestinal bleeding, severe hypoglycemia) within 3 months prior to screening.c) Use of any medication within 7 days or 5 half-lives (whichever is longer) prior to the first study drug administration that may affect HDM1002 pharmacokinetics (PK).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liyan Miao

Role: CONTACT

miaolysuzhou@163.com

0512-67972858

Facility Contacts

Liyan Miao

Role: primary

miaolysuzhou@163.com

Other Identifiers

HDM1002-109

Identifier Type: -

Identifier Source: org_study_id