NCT02396069已完成1 期
A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)
研究概览
简要总结
Double blind, randomized, placebo control, multiple dose, dose escalation study
详细描述
A phase I clinical study, randomized, double-blind, placebo-controlled, multiple doses, dose escalation study of the safety, tolerability and pharmacokinetics/pharmacodynamics of JPI-289 in healthy male volunteers.
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
- Double (Participant, Investigator)
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 form 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
Experimental
Each cohort, volunteers will be infused JPI-289 for 60 min. (6 volunteers per each cohort, total 3 cohort)
干预措施: JPI-289 (Drug)
Placebo
Placebo Comparator
Each cohort, volunteer will be infused placebo for 60 min. (2 volunteers per each cohort, total 3 cohort)
干预措施: Placebo (Drug)
结局指标
主要结局
AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)
时间窗: 96 hours, 73 hours
次要结局
- Cav,ss(96 hours)
- CL(96 hours)
- Vd,ss(96 hours)
- t1/2β(96 hours)
研究者
研究点 (1)
Loading locations...
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