Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC42 in Healthy Subjects

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 including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.

Key Inclusion Criteria:

• 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 Criteria:

• 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