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

Ascletis

Status and phase: Completed; Phase 1

Conditions: SARS CoV 2 Infection

Treatments: Drug: Placebo; Drug: ASC10

Study type: Interventional

Funder types: Industry

Identifiers

NCT05523141

ASC10-101

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

ASC10

Experimental group

Description:

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)

Treatment:

Drug: ASC10

Placebo

Placebo Comparator group

Description:

Part 1: Participants will be randomized to receive placebo

Treatment:

Drug: Placebo