An Phase I, Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ADC189 in Subjects With Hepatic Impairment (Child-Pugh A and B) Compared With Subjects With Normal Hepatic Function

2023-ADC189-I-001

This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of ADC189 in subjects with hepatic impairment compared with subjects with normal hepatic function.

2024-03-14

2024-09-30

2024-10-31

Recruiting

Early phase I

32

Inclusion Criteria: * 1) The subjects fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and can complete the entire trial process according to the requirements of the trial. * 2) Age 18-75 years old (including the boundary value), both male and female. * 3) The body weight of male subjects was ≥50 kg, the body weight of female subjects was ≥45 kg, and the body mass index (BMI) was within the range of 18.0\~30.0 kg/m². Exclusion Criteria: * 1) Known allergic history to test drug components, or allergic constitution, or history of allergic diseases. * 2) Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening. * 3) Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening. * 4) eGFR (CKD-EPI Cr) \<60mL/min/1.73m2.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}

2024-07-03