Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects
- Registration Number
- NCT05523141
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Part 1: Participants will be randomized to receive placebo ASC10 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)
- Primary Outcome Measures
Name Time Method 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 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 From screening through study completion, up to 12 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine🇨🇳Hangzhou, Zhejiang, China