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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Stroke

Treatments: Drug: JPI-289; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01983358

JP-NC-P1-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups, including a placebo group

JPI-289

Experimental group

Description:

Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort)

Treatment:

Drug: JPI-289

Placebo

Placebo Comparator group

Description:

Each cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort)

Treatment:

Other: Placebo