NCT01983358

The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Jeil Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.

Detailed description

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	JPI-289	PARP-1 inhibitor
OTHER	Placebo	Placebo

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2013-11-14
• Last updated: 2016-06-24

Locations

1 site across 1 country: South Korea