Status:
COMPLETED
To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects
Lead Sponsor:
Jiaxing AnDiCon Biotech Co.,Ltd
Conditions:
Influenza Type A
Influenza Type B
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 li...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06485401
Start Date
March 14 2024
End Date
June 21 2024
Last Update
January 20 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, China