A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- The number and incidence rate of adverse events
研究概览
简要总结
To evaluate the safety of single and repeated administration of TAS3731.
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 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male subjects who provided written informed consent to participate in the study
- •Aged 18 years or older and younger than 40 years at the time of informed consent
- •Body weight of 50 kg or more at screening:
- •Body mass index of 18.5 or more and less than 25.0 (Japanese) or less than 30.0 kg/m2 (Caucasian)
- •Capable of oral intake.
- •Key Exclusion Criteria
- •Complications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease. The stomach or small intestine has been resected.
- •The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.
- •Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
- •The patient has the following complications or a history of the following.
- •Had current or previous drug abuse (including use of illicit drugs) or alcoholism
- •Had current or previous hypersensitivity or allergy to drugs
- •Suspected COVID-19 disease.
排除标准
- 未提供
研究组 & 干预措施
Single dose cohort
干预措施: TAS3731 Dose1 (Drug)
Single dose cohort
干预措施: Placebo (Drug)
Repeated dose cohort Once daily (QD)
干预措施: TAS3731 Dose2 (Drug)
Repeated dose cohort Once daily (QD)
干预措施: Placebo (Drug)
Repeated dose cohort Twice daily (BID)
干预措施: TAS3731 Dose3 (Drug)
Repeated dose cohort Twice daily (BID)
干预措施: Placebo (Drug)
结局指标
主要结局
The number and incidence rate of adverse events
时间窗: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
Evaluation of pulse rate
时间窗: Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days
Evaluation of body temperature
时间窗: Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days
The number and incidence rate of adverse drug reactions
时间窗: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
Evaluation of Systolic and Diastolic blood pressure
时间窗: Single dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 7 days, Repeated dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 16 days
Number of participants with abnormal laboratory values
时间窗: Single dose cohort：Change in number of participants with abnormal laboratory values between baseline and 7 days, Repeated dose cohort：Change in number of participants with abnormal laboratory values between baseline and 16 days
Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval
时间窗: Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days
Evaluation of RR-interval
时间窗: Single dose cohort：Change from Baseline Evaluation of RR-interval at 7 days, Repeated dose cohort：Change from Baseline Evaluation of RR-interval at 16 days
次要结局
未报告次要终点