72
Participants
Start Date
January 13, 2023
Primary Completion Date
April 14, 2023
Study Completion Date
April 14, 2023
ASC11 tablets
"Part 1: Subjects will receive ASC11 tablets on single ascending doses with proposed dose levels of ASC11 tablets: 100mg (cohort 1), 200 mg (cohort 2), 400mg (cohort 3) and 800 mg (cohort 4).~Part 2: Subjects will receive ASC11tablets 100 to 300 mg (including 3 cohorts) and ASC11 tablets 300 mg(cohort 4) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6.~Part 3: Subjects will be randomized to receive ASC11 tablets two single 200 mg or 300 mg doses (fed or fasted)"
Placebo
Part 1 and 2: Subjects will be randomized to receive placebo.
RTV tablets
"Part 1: Subjects will receive RTV tablets on 100 mg (cohort 1-4). Part 2: Subjects will receive RTV tablets 100 mg (including 3 cohorts) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6.~Part 3: Subjects will be randomized to receive two single 100 mg doses (fed or fasted)"
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou
Lead Sponsor
Ascletis Pharmaceuticals Co., Ltd.
INDUSTRY