KCT0000936招募中未知
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.
Jeil Pharmaceutical0 个研究点目标入组 56 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1) Age 19 to 55 healthy male at the time of enrollment
- •2) Subject BMI must fall between the following at the time of enrollment
- •: 20 kg/m2= BMI =27 kg/m2
- •3) Subject blood pressure must fall between the following at the time of enrollment
- •: 90mmHg= systolic blood pressure =140mmHg
- •: 60mmHg= diastolic blood pressure =100mmHg
- •: 45bpm= pulse rate =100bpm
- •4) Written consent to participate in the screening/eligibility visit
- •5) Observation visit and blood sampling during the study period must be available.
- •6) Volunteers must agree with double-control contraception and no sperm provision from the dosing day of investigational product to 30 days later after the end of the trial.
排除标准
- •1) Volunteers have clinical significance and medical history such as liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, nervous and mental system, hemato-oncology system, cardiovascular system.
- •2) Volunteers have medical history such as skin ailment or skin transplantation which can affect absorbing investigational product.
- •3) Volunteers who have hypersensitivity for PARP-I inhibitor, same ingredient drug or other drug(aspirin, antibiotics) or who have medical history to clinically significant hypersensitivity.(except inactive allergic rhinitis)
- •4) Volunteers who have medical history of drug abuse.
- •5) Volunteers who have positive results for concerning drug abuse to urinary test in screening visit.
- •6) Volunteers who have medicated other investigational product within 60 days before screening visit.
- •7) Volunteers who donated whole blood within 60 days before screening visit.
- •8) Volunteers who donated Ingredient blood within 30 days before screening visit.
- •9) Volunteers who received blood transfusion within 30 days before screening visit.
- •10) Volunteers who got sick as clinically significant diseases within 30 days before screening visit.
- •11) Volunteers who took a medicine which can affect chronically to drug absorption or elimination within 30 days before screening visit.
- •12) Volunteers who took a herbal medicine within 14 days before screening visit. (Except, if other conditions are fit, volunteers can participate in this clinical trial based on investigator’s judgment.)
- •13) Volunteers who took prescription medicines within 14 days before screening visit. (Except, if other conditions are fit, volunteers can participate in this clinical trial based on investigator’s judgment.)
- •14) Volunteers who took medicines within 7 days before screening visit. (Except, if other conditions are fit, volunteers can participate in this clinical trial based on investigator’s judgment.)
- •15) Volunteers who had abnormal diet which can affect to absorption, distribution, metabolism, excretion of drug.
- •16) Excessive caffeine intake (caffeine > 5 units/day)
- •17) Excessive alcohol intake (alcohol > 21units/week)
- •18) Heavy smoker (cigarette > 10 cigarettes/day)
- •19) AST, ALT, and r-GT are excessive more than 2 times from the upper normal range or total bilirubin is excessive more than 1.5 times from the upper normal range.
- •20) Serum test results are positive.
- •21) Electrocardiogram test result (QTcB) is > 450msec
- •22) Except exclusion criteria 19, 21 and inclusion criteria 3, volunteers who unfit to the clinical trials because of laboratory test, electrocardiogram test and vital sign test results based on investigator’s judgment.
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