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

NCT06485401 | Completed Phase 1 DMC

• 1 other identifier: 2023-ADC189-I-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza Type A; Influenza Type B

Outcome Measures

Primary Outcomes (2)

• Cmax of ADC189/ADC189-I07

  15 days

• AUClast of ADC189/ADC189-I07

  15 days

Study Arms (4)

ADC189 to Child-Pugh Class A

EXPERIMENTAL

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

Drug: ADC189

ADC189 to normal haptic function (A)

EXPERIMENTAL

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

Drug: ADC189

ADC189 to Child-Pugh Class B

EXPERIMENTAL

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

Drug: ADC189

ADC189 to normal haptic function (B)

EXPERIMENTAL

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

Drug: ADC189

Interventions

ADC189 DRUG

45 mg per tablet, oral administration, single dose.

ADC189 to Child-Pugh Class A; ADC189 to Child-Pugh Class B; ADC189 to normal haptic function (A); ADC189 to normal haptic function (B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• \) Age 18-75 years old (including the boundary value), both male and female.
• \) 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.

You may not qualify if:

• \) Known allergic history to test drug components, or allergic constitution, or history of allergic diseases.
• \) Have malignant tumors, or have a history of malignant tumors within 5 years prior to screening.
• \) Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening.
• \) eGFR (CKD-EPI Cr) \<60mL/min/1.73m2.

Sponsors & Collaborators

• Jiaxing AnDiCon Biotech Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: July 3, 2024
• Study Start: March 14, 2024
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)