A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled,Single Dose, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of JPI-289 in Healthy Male Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group
研究概览
简要总结
The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.
详细描述
tPA treatment should be used within 3 hours after stroke onset for treating efficacy, but JPI-289 treatment(PARP-1 inhibitor) showed treating efficacy more than 10 hours after stroke onset. PARP-1 inhibitor add-on therapy of tPA will be very useful to prevent social, economic loss from physical, and mental disable by stroke.
This clinical trial progresses to explore safety, tolerability, pharmacokinetic/pharmacodynamic properties of JPI-289 by single dose escalation(7cohort). Investigational product medication of each level within 4 weeks evaluate safety and tolerability of patient through Data Safety Monitoring Board(DSMB) which is composed of more than 3 experts except principal investigator until the last visit. In each level 6 patients for investigational product and 2 patients for placebo will be allocated respectively in double blind manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •19~55 years healthy male
- •BMI measurement 20kg/m²~27kg/m²
- •90 ≤ SBP<140(mmHg) 60 ≤ DBP<100(mmHg) 45 ≤ Pulse rate<100(bpm)
- •Signed the informed consent from to participate voluntarily and to comply with the trial requirements
- •For a follow-up visit and during the study period, blood samples and availability
排除标准
- •History of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (Specially asthma, obstructive pulmonary disease, peptic ulcer)
- •History of skin disease of graft affecting absorption of the drug
- •History of drug abuse
- •Positive urine drug screening
- •Administrated investigational product in a previous clinical trial within 60 days of the screening test
- •Donated blood within 60 days prior to screening test
研究组 & 干预措施
JPI-289
Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort)
干预措施: JPI-289 (Drug)
Placebo
Each cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort)
干预措施: Placebo (Other)
结局指标
主要结局
Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group
时间窗: -21d~9d
次要结局
- Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group(0h~48h , 15 points)