drugset / Trial / NCT03758612

A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults

NCT03758612

Phase 1 Completed 86 enrolled Global Alliance for TB Drug Development
RandomizedParallel-groupTriple-blindTreatment

Summary

Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.

Timeline

Start
2019-01-16
Primary completion
2020-03-15
Completion
2020-03-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator TBI-223 Small molecule 50 mg Oral
Comparator TBI-223 Small molecule 100 mg Oral
Comparator TBI-223 Small molecule 300 mg Oral
Comparator TBI-223 Small molecule 600 mg Oral
Comparator TBI-223 Small molecule 1200 mg Oral
Comparator TBI-223 Small molecule 1800 mg Oral
Comparator TBI-223 Small molecule 2000 mg Oral
Comparator TBI-223 Small molecule 2600 mg Oral