A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers

INTERVENTION: OSKLIPO‐0524 0.15 mg/kg, single administration OSKLIPO‐0524 0.5 mg/kg, single administration OSKLIPO‐0524 1.0 mg/kg, single administration Placebo CONDITION: Acute myocardial infarction PRIMARY OUTCOME: Pharmacokinetic parameters (Cmax, T1/2, AUC) of cyclosporine SECONDARY OUTCOME: Saftey INCLUSION CRITERIA: 1)Japanese healthy male age >=20 years and <= 40 years old at the time of informed consent 2)Japanese healthy male who passes screening tests and examination before administration of the drug 3)After receiving a sufficient explanation upon participation in this trial, on a full understanding, Japanese healthy male who obtained the written informed consent from each subject