To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06485401

Enrollment

Registered

2024-07-03

Start date

2024-03-14

Completion date

2024-06-21

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Type A, Influenza Type B

Brief summary

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.

Detailed description

The evaluation of ADC189/ADC189-I07 in mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B) the pharmacokinetic characteristics in subjects, compared with normal liver function subjects, which matched by sex, age, and BMI, in order to provide a scientific basis for a reasonable dosage in patients with liver dysfunction.

Interventions

DRUGADC189

45 mg per tablet, oral administration, single dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Cmax of ADC189/ADC189-I07	15 days
AUClast of ADC189/ADC189-I07	15 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026