Overview
A Study to Assess the Safety and Pharmacokinetics of AD-104-A
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-12-01
2023-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-104-APhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Addpharma Inc.
Criteria
Inclusion Criteria:For all subjects
- Adults aged 19 years and older
- Body mass index(BMI) of 18 to 30 kg/m2
- Voluntarily given written informed consent
For renal Impairment subjects
- 30 ≤ eGFR < 90 mL/min/1.73m^2
For healthy subjects
- eGFR ≥ 90 mL/min/1.73m^2
Exclusion Criteria:
- Participation in another clinical study with an investigational drug within the 6
months from scheduled first administration
- Other exclusions applied