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Clinical trial

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

ID
Name
ASC10-101
Description
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
Trial arms
Trial start
2022-10-07
Estimated PCD
2022-11-18
Trial end
2022-12-05
Status
Completed
Phase
Early phase I
Treatment
ASC10
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
Arms:
ASC10
Placebo
Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner
Arms:
Placebo
Size
72
Primary endpoint
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
Part1: Number of Participants With Laboratory Abnormalities in MAD
From screening through study completion, up to 12 days
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\^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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}
Updated at
2022-12-16

1 organization

2 products

1 indication

Organization
Ascletis Pharmaceuticals
Product
Placebo
Indication
COVID-19
Product
ASC10