A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers
- Conditions
- Acute myocardial infarction
- Registration Number
- JPRN-UMIN000018828
- Lead Sponsor
- Osaka University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 20
Not provided
1) A subject who has cardiovascular,kidney, liver, blood or autoimmune system diseases 2) BMI (kg/m2) <17.5 or >=30.0 3) A subject who has HCV Ab, HIV Ab, HBs Ag positive by screening test 4) A subject who has or is suspected to have the past of clinically significant drug allergy symptoms 5) A subject who has or is suspected to have the past of significant allergic diseases including bronchial asthma, urticaria or atopy, but not seasonal allergy 6) A subject with diseases and symptoms requiring systemic drugs 7) A subject who has or suspeted to have a past histroy of drug or alcohol dependency 8) A subject who received vaccine within four months 9) A subject who participated in other clinical trials within 4 months and received a clinical trial drug (including a placebo) 10) A subject taking prescribed drugs and/or Over-The-Counter drugs 11) Ineligible judged by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters (Cmax, T1/2, AUC) of cyclosporine
- Secondary Outcome Measures
Name Time Method Saftey