COVID-19, Healthy
Conditions
Keywords
COVID-19, ASC11, 3CL-pro
Brief summary
This is a randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, and pharmacokinetics of ASC11 plus ritonavir tablets in healthy subjects and an open-label, cross-over study evaluating the effect of food on the pharmacokinetics of ASC11 plus ritonavir tablets
Interventions
DRUGASC11 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)
DRUGPlacebo
Part 1 and 2: Subjects will be randomized to receive placebo.
DRUGRTV 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)
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) of ASC11 relative to placebo | From screening through study completion, up to 14 days | To evaluate the safety and tolerability of ASC11 tablets combined with Ritonavir tablets in healthy subjects given single and multiple dose increments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Title Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-inf | From screening through study completion, up to 14 days | Area under the concentration-time curve from the time of dosing extrapolated to time infinity |
| Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Tmax | From screening through study completion, up to 14 days | Time to Maximum Observed Plasma Concentration |
| Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-t | From screening through study completion, up to 14 days | Area under the concentration-time curve from the time of dosing to the last measurable concentration |
| Title -Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Cmax | From screening through study completion, up to 14 days | Maximum concentration |
| Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: CL/F | From screening through study completion, up to 14 days | Apparent total systemic clearance |
| Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Vz/F | From screening through study completion, up to 14 days | Apparent volume of distribution during the terminal elimination phase |
| Pharmacokinetics (PK) parameter of ASC11 tablets in Urine: CLR | From screening through study completion, up to 14 days | Renal clearance |
| Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: T1/2 | From screening through study completion, up to 14 days | Elimination half-life |
Countries
China
Outcome results
None listed