Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects
Healthy, COVID-19
About this trial
This is an interventional treatment trial for Healthy focused on measuring COVID-19, ASC11, 3CL-pro
Eligibility Criteria
Inclusion Criteria: Healthy male or female subjects aged 18-60 years (including boundary values) If a woman has no planned pregnancy within 6 months after signing the informed consent, and is willing to use effective contraception (e.g. condom, uterine cap, non-hormonal intrauterine device [IUD]) for at least 3 months from the first administration of the study intervention to the last administration of the study intervention; Or not fertile (e.g. surgical sterilization [bilateral oophorectomy, tubal ligation, or hysterectomy] or natural sterilization [continuous > 12 months without menstruation]) If male, agree to use effective contraception throughout the study intervention and for at least 3 months after the last dose of the study intervention, and do not donate sperm. General good health based on history, physical examination (screening and check-in assessment), vital signs and other screening assessments. Able to understand the research content, comply with the research protocol, and voluntarily sign the informed consent. Exclusion Criteria: Pregnant and lactating women. Patients with acute or chronic diseases, including but not limited to cardiovascular, digestive, respiratory, urinary, nervous, endocrine, immune, musculoskeletal, and skin conditions, were judged by the investigator. Any previous or existing hematological disorders or disorders, major liver disease, family history of bleeding/platelet disease. Previous or existing cancer (other than basal cell carcinoma or squamous cell carcinoma of the skin), or hygrosis. Have an autoimmune disease, immunosuppression, or any form of immune deficiency.
Sites / Locations
- The First Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
ASC11 tablets
RTV tablets
Placebo
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)
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)
Part 1 and 2: Subjects will be randomized to receive placebo