Phase 1 Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects

Study Director
Paul Bruinenberg, MD Global Alliance for TB Drug Development
Start Date
9 / 2021
Trial Phase
Phase I
Trial Status
Current Enrollment
Target Enrollment

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.

Developer Associations
Compound Associations