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

Phase 1CompletedNCT01983358

Jeil Pharmaceutical Co., Ltd.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Stroke

Interventions

JPI-289DRUG

PARP-1 inhibitor

PlaceboOTHER

Placebo

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 19\~55 years healthy male * BMI measurement 20kg/m²\~27kg/m² * 90 ≤ SBP\<140(mmHg) 60 ≤ DBP\<100(mmHg) 45 ≤ Pulse rate\<100(bpm) * Signed the informed consent from to participate voluntarily and to comply with the trial requirements * For a follow-up visit and during the study period, blood samples and availability Exclusion Criteria: * History of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (Specially asthma, obstructive pulmonary disease, peptic ulcer) * History of skin disease of graft affecting absorption of the drug * History of drug abuse * Positive urine drug screening * Administrated investigational product in a previous clinical trial within 60 days of the screening test * Donated blood within 60 days prior to screening test

Locations (1)

Asan Medical Center

Seoul, Song-Pa Gu, South Korea

Outcomes

Primary Outcomes

Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group

Time frame: -21d~9d

Secondary Outcomes

Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group

* Blood * Urine 0h(pre-dose), 5min, 10min, 20min, 30min(before termination of infusion JPI-289), 45min, 1h, 2h, 4h, 8h, 12h, 24h, 48h

Time frame: 0h~48h , 15 points

Data from ClinicalTrials.gov

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