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

• Status: Not yet recruiting
• Trial end date: 2023-01-05
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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^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.