The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers
JPI-289
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.
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 stroke
Started Nov 2013
Shorter than P25 for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 4, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJune 24, 2016
September 1, 2014
9 months
November 4, 2013
June 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference of ECG, vital sign and diagnostic test in JPI-289 group and placebo group
-21d~9d
Secondary Outcomes (1)
Difference of concentration of JPI-289 in Plasma between JPI-289 group and placebo group
0h~48h , 15 points
Other Outcomes (1)
Difference of PAR level in PBMC between JPI-289 group and placebo group
0h(pre-dose)~48h, 6 points
Study Arms (2)
JPI-289
EXPERIMENTALEach cohort, volunteers will be infused JPI-289 through I.V for 30 min.(6 volunteers per each cohort, total 7 cohort)
Placebo
PLACEBO COMPARATOREach cohort, volunteer will be infused placebo through I.V for 30 min.(2 volunteers per each cohort, total 7 cohort)
Interventions
Eligibility Criteria
You may qualify if:
- \~55 years healthy male
- BMI measurement 20kg/m²\~27kg/m²
- ≤ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, Song-Pa Gu, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HyeongSeok Lim, M.D.,Ph.D.
AIDS Malignancy Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2013
First Posted
November 14, 2013
Study Start
November 1, 2013
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
June 24, 2016
Record last verified: 2014-09
Data Sharing
- IPD Sharing
- Will not share