KCT0000936
Recruiting
未知
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.
Jeil Pharmaceutical0 sites56 target enrollmentTBD
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Jeil Pharmaceutical
- Enrollment
- 56
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age 19 to 55 healthy male at the time of enrollment
- •2\) Subject BMI must fall between the following at the time of enrollment
- •: 20 kg/m2\= BMI \=27 kg/m2
- •3\) Subject blood pressure must fall between the following at the time of enrollment
- •: 90mmHg\= systolic blood pressure \=140mmHg
- •: 60mmHg\= diastolic blood pressure \=100mmHg
- •: 45bpm\= pulse rate \=100bpm
- •4\) Written consent to participate in the screening/eligibility visit
- •5\) Observation visit and blood sampling during the study period must be available.
- •6\) Volunteers must agree with double\-control contraception and no sperm provision from the dosing day of investigational product to 30 days later after the end of the trial.
Exclusion Criteria
- •1\) Volunteers have clinical significance and medical history such as liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, nervous and mental system, hemato\-oncology system, cardiovascular system.
- •2\) Volunteers have medical history such as skin ailment or skin transplantation which can affect absorbing investigational product.
- •3\) Volunteers who have hypersensitivity for PARP\-I inhibitor, same ingredient drug or other drug(aspirin, antibiotics) or who have medical history to clinically significant hypersensitivity.(except inactive allergic rhinitis)
- •4\) Volunteers who have medical history of drug abuse.
- •5\) Volunteers who have positive results for concerning drug abuse to urinary test in screening visit.
- •6\) Volunteers who have medicated other investigational product within 60 days before screening visit.
- •7\) Volunteers who donated whole blood within 60 days before screening visit.
- •8\) Volunteers who donated Ingredient blood within 30 days before screening visit.
- •9\) Volunteers who received blood transfusion within 30 days before screening visit.
- •10\) Volunteers who got sick as clinically significant diseases within 30 days before screening visit.
Outcomes
Primary Outcomes
Not specified
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