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.
Overview
- Phase
- Phase 1
- Intervention
- JPI-289
- Conditions
- Stroke
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
JPI-289
Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort)
Intervention: JPI-289
Placebo
Each cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort)
Intervention: Placebo
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(0h~48h , 15 points)