Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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SARS CoV 2 Infection

Intervention / Treatment
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* Drug: ASC10
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC10<br>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) | Drug: ASC10<br>* 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<br>|
| Placebo Comparator: Placebo<br>Part 1: Participants will be randomized to receive placebo | Drug: Placebo<br>* Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Vital signs evaluation includes: systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate. | From screening through study completion, up to 12 days | 
| Part1: Number of Participants With Laboratory Abnormalities in MAD |  | From screening through study completion, up to 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASC10, RdRp, Healthy