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CompletedNCT02396069Updated Jun 24, 2016

The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers

A Phase 1 interventional study of JPI-289 and Placebo in Stroke, sponsored by Jeil Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-24.

Sponsored by Jeil Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
Male
01

Study summary

Double blind, randomized, placebo control, multiple dose, dose escalation study

Read the detailed description

A phase I clinical study, randomized, double-blind, placebo-controlled, multiple doses, dose escalation study of the safety, tolerability and pharmacokinetics/pharmacodynamics of JPI-289 in healthy male volunteers.

02

Conditions studied

  • Stroke
03

In context

Lead sponsor

Jeil Pharmaceutical Co., Ltd. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
Male
Accepts 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 form 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    JPI-289

    Each cohort, volunteers will be infused JPI-289 for 60 min. (6 volunteers per each cohort, total 3 cohort)

    Drug: JPI-289

  • Placebo comparator
    Placebo

    Each cohort, volunteer will be infused placebo for 60 min. (2 volunteers per each cohort, total 3 cohort)

    Drug: Placebo

Interventions

  • DrugJPI-289

    PARP-1 inhibitor

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)

    Time frame: 96 hours, 73 hours

Secondary outcomes

  1. Cav,ss

    Time frame: 96 hours

  2. t1/2β

    Time frame: 96 hours

  3. Vd,ss

    Time frame: 96 hours

  4. CL

    Time frame: 96 hours

07

Study locations

1 site
  • Asan Medical Center
    Seoul, Songpa-Gu 138-736, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02396069
Lead sponsor
Jeil Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 24, 2015
Start date
Mar 2015
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Jun 24, 2016

Study contacts

Hyeong-Seok Lim, M.D.,Ph.D.
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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