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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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^
- •Weight ≥50 kg for males and ≥45 kg for females.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: ASC10 (Drug)
Placebo
Part 1: Participants will be randomized to receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
时间窗: From screening through study completion, up to 12 days
Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD
时间窗: 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
时间窗: From screening through study completion, up to 12 days
次要结局
未报告次要终点