Status:
COMPLETED
Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects
Lead Sponsor:
Gannex Pharma Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a first in human study of single and multiple ascending doses and food effect of ASC42. This study consists of 8 cohorts and is divided as follows: Part Ia: Single ascending doses study incl...
Eligibility Criteria
Inclusion
- Key
- Healthy male and female subjects between 18 to 65 years of age.
- Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m2.
- Physical examination and vital signs are within normal range or slightly abnormal.
- Key
Exclusion
- History or current liver disease, or liver injuries.
- A positive HBsAg, HCV Ab and/or HIV Ab.
- Platelet count \<150,000/mcL
- INR\> 1.2
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04679129
Start Date
November 30 2020
End Date
June 3 2021
Last Update
September 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ICON early Phase Services LLC
San Antonio, Texas, United States, 78209