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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01983358

Acronym

JPI-289

Enrollment

Registered

2013-11-14

Start date

2013-11-30

Completion date

2014-09-30

Last updated

2016-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

PARP-1 inhibitor

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.

Interventions

DRUGJPI-289

PARP-1 inhibitor

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Difference of PAR level in PBMC between JPI-289 group and placebo group	0h(pre-dose)~48h, 6 points	-Blood 0h(pre-dose),1h, 4h, 7h, 24h, 48h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026