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

NCT ID: NCT06485401

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-14
• Study Completion Date: 2024-06-21

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.

Conditions

Influenza Type A; Influenza Type B

Study Design

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

Study Groups

ADC189 to Child-Pugh Class A

Subjects with Child-Pugh Class A received a single dose once of ADC189 (45 mg/1 tablet).

Group Type: EXPERIMENTAL

ADC189

Intervention Type: DRUG

45 mg per tablet, oral administration, single dose.

ADC189 to normal haptic function (A)

Healthy subjects who marched with Group "Child-Pugh Class A", that received a single dose of ADC189 (45 mg/1 tablet).

Group Type: EXPERIMENTAL

ADC189

Intervention Type: DRUG

45 mg per tablet, oral administration, single dose.

ADC189 to Child-Pugh Class B

Subjects with Child-Pugh Class B received a single dose once of ADC189 (45 mg/1 tablet).

Group Type: EXPERIMENTAL

ADC189

Intervention Type: DRUG

45 mg per tablet, oral administration, single dose.

ADC189 to normal haptic function (B)

Healthy subjects who marched with Group "Child-Pugh Class B", that received a single dose of ADC189 (45 mg/1 tablet).

Group Type: EXPERIMENTAL

ADC189

Intervention Type: DRUG

45 mg per tablet, oral administration, single dose.

Interventions

ADC189

45 mg per tablet, oral administration, single dose.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiaxing AnDiCon Biotech Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, , China

Countries

China

Other Identifiers

2023-ADC189-I-001

Identifier Type: -

Identifier Source: org_study_id