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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JPI-289 | Experimental | Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort) |
|
| Placebo | Placebo Comparator | Each cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JPI-289 | Drug | PARP-1 inhibitor |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group | -21d~9d |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group |
| 0h~48h , 15 points |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of PAR level in PBMC between JPI-289 group and placebo group | -Blood 0h(pre-dose),1h, 4h, 7h, 24h, 48h | 0h(pre-dose)~48h, 6 points |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HyeongSeok Lim, M.D.,Ph.D. | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Song-Pa Gu | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000625768 | JPI-289 |
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| Other |
Placebo |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |