Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects

A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to active drug and 2 subjects randomized to placebo). Five dose levels (2, 5, 10, 20 and 30 mg) are planned to be evaluated.The study will be double blinded with regard to treatment (KPG-818 or placebo) at each dose level. KPG-818 and placebo will be matched for formulation, appearance and number of capsules. Safety assessments will be performed throughout the study including physical examinations, vital signs, clinical laboratory tests, 12 lead electrocardiograms and monitoring of adverse events. Pharmacokinetic blood and urine samples will be collected up to 72 hours after dosing. A post-treatment follow-up visit will be performed within 10 days of the last dose of study treatment.