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

Phase 1

Completed

• Conditions: Stroke
• Interventions: Drug: JPI-289; Other: Placebo

• Registration Number: NCT01983358
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-14
• Primary Completion: 2014-08
• Status Verified: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JPI-289	JPI-289	Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort)
Placebo	Placebo	Each cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort)

Primary Outcome Measures

Name	Time	Method
Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group	-21d~9d

Secondary Outcome Measures

Name	Time	Method
Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group	0h~48h , 15 points	* Blood; * Urine 0h(pre-dose), 5min, 10min, 20min, 30min(before termination of infusion JPI-289), 45min, 1h, 2h, 4h, 8h, 12h, 24h, 48h

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Song-Pa Gu, Korea, Republic of