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

Phase 1

Completed

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: JPI-289

• Registration Number: NCT02396069
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Each cohort, volunteer will be infused placebo for 60 min. (2 volunteers per each cohort, total 3 cohort)
JPI-289	JPI-289	Each cohort, volunteers will be infused JPI-289 for 60 min. (6 volunteers per each cohort, total 3 cohort)

Primary Outcome Measures

Name	Time	Method
AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%)	96 hours, 73 hours

Secondary Outcome Measures

Name	Time	Method
Cav,ss	96 hours
CL	96 hours
Vd,ss	96 hours
t1/2β	96 hours

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of