The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.
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.
- Placebo Drug
Intervention Desc: Placebo ARM 1: Kind: Experimental Label: Placebo Description: Each cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort)
- JPI-289 Drug
Intervention Desc: PARP-1 inhibitor ARM 1: Kind: Experimental Label: JPI-289 Description: Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort)
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Endpoint: Pharmacokinetics/Dynamics Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Difference of ECG, vital sign and diagnotic test in JPI-289 group and placebo group||-21d~9d||Yes|
|Secondary||Difference of consentration of JPI-289 in Plasma between JPI-289 group and placebo group||0h~48h , 15 points||Yes|
|Primary||Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group||-21d~9d||Yes|
|Secondary||Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group||0h~48h , 15 points||Yes|