Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

January 13, 2023

Primary Completion Date

April 14, 2023

Study Completion Date

April 14, 2023

Conditions
HealthyCOVID-19
Interventions
DRUG

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)"

DRUG

Placebo

Part 1 and 2: Subjects will be randomized to receive placebo.

DRUG

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)"

Trial Locations (1)

310003

The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

NCT05718518 - Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects | Biotech Hunter | Biotech Hunter