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

Phase 1

Completed

• Conditions: Influenza Type A; Influenza Type B
• Interventions: Drug: ADC189

• Registration Number: NCT06485401
• Lead Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

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.

Study Timeline

• Study Start: 2024-03-14
• Status Verified: 2024-06
• Study First Submitted: 2024-06-15
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Study First Submitted QC: 2024-06-29
• Study First Posted: 2024-07-03
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADC189 to normal haptic function (A)	ADC189	Healthy subjects who marched with Group "Child-Pugh Class A", that received a single dose of ADC189 (45 mg/1 tablet).
ADC189 to Child-Pugh Class A	ADC189	Subjects with Child-Pugh Class A received a single dose once of ADC189 (45 mg/1 tablet).
ADC189 to Child-Pugh Class B	ADC189	Subjects with Child-Pugh Class B received a single dose once of ADC189 (45 mg/1 tablet).
ADC189 to normal haptic function (B)	ADC189	Healthy subjects who marched with Group "Child-Pugh Class B", that received a single dose of ADC189 (45 mg/1 tablet).

Primary Outcome Measures

Name	Time	Method
Cmax of ADC189/ADC189-I07	15 days
AUClast of ADC189/ADC189-I07	15 days

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China