StrokePhase 1JPI-289NCT01983358
The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers
A Phase 1 study testing JPI-289 in people with Stroke, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- JPI-289
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.
Read the 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.
- Conditions
- Stroke
- Being tested
- JPI-289, Placebo
- Keywords
- PARP-1 inhibitor
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPI-289Drug
PARP-1 inhibitor
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| JPI-289 | Experimental | Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort) Receives: Drug: JPI-289 |
| Placebo | Placebo comparator | Each cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group
Measured: -21d~9d
Secondary outcomes (1)
Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group
- Blood
- Urine 0h(pre-dose), 5min, 10min, 20min, 30min(before termination of infusion JPI-289), 45min, 1h, 2h, 4h, 8h, 12h, 24h, 48h
Measured: 0h~48h , 15 points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HyeongSeok Lim, M.D.,Ph.D., Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983358
- Sponsor's protocol ID
- JP-NC-P1-13
- Acronym
- JPI-289
- Status last verified
- Sep 2014
- First submitted
- 4 Nov 2013
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01983358
- Acronym / sponsor ID
- JPI-289 / JP-NC-P1-13
- Conditions
- Stroke
- Keywords
- PARP-1 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JPI-289 | Experimental | Drug: JPI-289Each cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort) |
| Placebo | Placebo comparator | Other: PlaceboEach cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JPI-289PARP-1 inhibitor | Drug | JPI-289 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group
Time frame: -21d~9d
1 secondary outcome
Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group
Time frame: 0h~48h , 15 points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HyeongSeok Lim, M.D.,Ph.D. principal investigator
AIDS Malignancy Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JPI-289 in people with Stroke, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group (time frame: -21d~9d). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.