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Double blind, randomized, placebo control, multiple dose, dose escalation study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JPI-289 | Experimental | Each cohort, volunteers will be infused JPI-289 for 60 min. (6 volunteers per each cohort, total 3 cohort) |
|
| Placebo | Placebo Comparator | Each cohort, volunteer will be infused placebo for 60 min. (2 volunteers per each cohort, total 3 cohort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JPI-289 | Drug | PARP-1 inhibitor |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss and Cmax,ss(76h), Relative PAR level(73h,%) | 96 hours, 73 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cav,ss | 96 hours | |
| t1/2β | 96 hours | |
| Vd,ss | 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyeong-Seok Lim, M.D.,Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-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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| Drug |
Placebo |
|
| CL | 96 hours |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |