Actively Recruiting
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
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-05-22
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
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 drug's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese adults aged 18 to 70 years inclusive at screening
- Both males and females are eligible
- Male subjects must weigh at least 50.0 kg
- Female subjects must weigh at least 40.0 kg
- Body Mass Index (BMI) between 19.0 and 32.0 kg/m² inclusive
- Normal hepatic function and hepatic impairment groups must be matched by age within ±10 years
- Normal hepatic function and hepatic impairment groups must be matched by weight within ±10 kg
- Gender matching within ±1 subject per gender between groups
You will not qualify if you...
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2
- Serum calcitonin greater than or equal to 50 ng/L at screening
- History of chronic pancreatitis or acute pancreatitis within 3 months prior to consent
- History of acute gallbladder disease within 3 months prior to consent
- Diagnosis of any malignancy within 5 years prior to consent, except cured basal cell carcinoma
- History of severe cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, or other systemic diseases within 1 year prior to consent
- Conditions that may affect drug absorption or metabolism such as dysphagia, inflammatory bowel disease, gastrectomy, or intestinal resection
- Episode of severe hypoglycemia within 3 months prior to screening
- History of allergic diseases or known intolerance to GLP-1 receptor agonists
- For normal hepatic function group: history of chronic liver disease or positive hepatitis B or C tests, positive Treponema pallidum antibody, or use of any medication within 28 days before study drug
- For hepatic impairment group: hepatocellular carcinoma, hepatorenal syndrome, limited life expectancy under 1 year, cirrhosis complications within 3 months prior to screening, or use of medications affecting HDM1002 pharmacokinetics within 7 days before study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 hours post dose
Participants receive a single dose of HDM1002 on Day 1 and undergo pharmacokinetic assessments.
Multiple visits over 3 days for blood sampling
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
L
Liyan Miao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here