The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers "JPI-289"

Completed

Phase 1 Results N/A

Trial Description

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

Interventions

  • 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)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Endpoint: Pharmacokinetics/Dynamics Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors