This is a partially-blinded, placebo-controlled, randomized multiple ascending dose (MAD) study toinclude a single dose food-effect study to evaluate the safety, tolerability, and the PK profile of TBI-223. Thirty-six (36) subjects will be enrolled in 3 cohorts with 12 subjects per cohort. Within each cohort, 9 subjects will be assigned to receive active treatment and 3 subjects will receive placebo.  Drug: 1800 mg TBI-223, 2400mg TBI-223, 3000mg TBI-223 vs Placebo.