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

AnDiCon Biotech

Status and phase: Completed; Phase 1

Conditions: Influenza Type B; Influenza Type A

Treatments: Drug: ADC189

Study type: Interventional

Funder types: Industry

Identifiers

NCT06485401

2023-ADC189-I-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

ADC189 to Child-Pugh Class A

Experimental group

Description:

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

Treatment:

Drug: ADC189

ADC189 to normal haptic function (A)

Experimental group

Description:

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

Treatment:

Drug: ADC189

ADC189 to Child-Pugh Class B

Experimental group

Description:

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

Treatment:

Drug: ADC189

ADC189 to normal haptic function (B)

Experimental group

Description:

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

Treatment:

Drug: ADC189