SARS CoV 2 Infection
Conditions
Keywords
ASC10, RdRp, Healthy
Brief summary
This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to evaluate the food effect on PK of ASC10 in healthy subjects
Interventions
DRUGASC10
Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo for 5.5 days, in an double-blind manner Part 2: Two single oral doses of ASC10 will be administered to participants, in an open-label manner
DRUGPlacebo
Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteers between the ages 18 and 45, inclusive * Those 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. * If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug. * Body mass index (BMI) was between 19 and 26 kg/m\^2. Weight ≥50 kg for males and ≥45 kg for females.
Exclusion criteria
* Females who are pregnant, planning to become pregnant, or breastfeeding. * Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders. * Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias. * Has a history of blood dizziness or difficulty in blood collection. * Has donated blood within 30 days, plasma within 2 weeks, or platelets within 6 weeks before the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD) | From screening through study completion, up to 12 days | — |
| Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD | From screening through study completion, up to 12 days | Vital signs evaluation includes: systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate. |
| Part1: Number of Participants With Laboratory Abnormalities in MAD | From screening through study completion, up to 12 days | — |
Countries
China
Outcome results
None listed