NCT02396069
Completed
Phase 1
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.
Overview
- Phase
- Phase 1
- Intervention
- JPI-289
- Conditions
- Stroke
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Double blind, randomized, placebo control, multiple dose, dose escalation study
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.
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 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
- •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 for 60 min. (6 volunteers per each cohort, total 3 cohort)
Intervention: JPI-289
Placebo
Each cohort, volunteer will be infused placebo for 60 min. (2 volunteers per each cohort, total 3 cohort)
Intervention: Placebo
Outcomes
Primary Outcomes
AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)
Time Frame: 96 hours, 73 hours
Secondary Outcomes
- Cav,ss(96 hours)
- CL(96 hours)
- Vd,ss(96 hours)
- t1/2β(96 hours)
Study Sites (1)
Loading locations...
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