SARS CoV 2 Infection
Conditions
Keywords
ASC10, RdRp
Brief summary
This is a phase Ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in mild or moderate COVID-19 subjects.
Interventions
DRUGASC10
Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
DRUGPlacebo
Participants will be randomized to receive placebo
Sponsors
Ascletis Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged ≥18 years at screening; 2. Those females who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose; 3. If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug; 4. Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization.
Exclusion criteria
1. Females who are pregnant, planning to become pregnant, or breastfeeding; 2. Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19; 3. Has hypersensitivity or other contraindication to any of the components of the study interventions; 4. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses | From Day 0 to Study Completion, up to 32 days |
| PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h | From Day 1 to Day 6 |
Secondary
| Measure | Time frame |
|---|---|
| Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms | From Day 1 to Study Completion, up to 32 days |
Countries
United States
Outcome results
None listed