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
Overview
- Phase
- Phase 1
- Intervention
- ASC10
- Conditions
- SARS CoV 2 Infection
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
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\^
- •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.
Arms & Interventions
ASC10
Part 1: Participants will be randomized to receive 100 to 1600 mg ASC10 (including 6 cohorts) in an double-blind manner Part 2: Participants will be randomized to receive two single 800 mg doses (fed or fasted)
Intervention: ASC10
Placebo
Part 1: Participants will be randomized to receive placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
Time Frame: From screening through study completion, up to 12 days
Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD
Time Frame: 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
Time Frame: From screening through study completion, up to 12 days