drugset
drugset / Trial / NCT04493671

Evaluate Safety, Tolerability, PK of TBAJ-876 in Healthy Adults

NCT04493671 ↗

Phase 1 Completed 137 enrolled Global Alliance for TB Drug Development
RandomizedParallel-groupTriple-blindTreatment

Summary

A Phase 1, Partially Blind, Placebo Controlled, Randomized, Combined Single Ascending Dose (SAD) with a Food Effect Cohort (Part 1), Multiple Ascending Dose (MAD) (Part 2), and Relative Bioavailability (rBA) (Part 3) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBAJ-876 in Healthy Adult Subjects

Timeline

Start
2020-06-08
Primary completion
2022-06-16
Completion
2022-11-15

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator TBAJ-876 Small molecule 10 mg Oral
Comparator TBAJ-876 Small molecule 25 mg Oral
Comparator TBAJ-876 Small molecule 50 mg Oral
Comparator TBAJ-876 Small molecule 75 mg Oral
Comparator TBAJ-876 Small molecule 100 mg Oral
Comparator TBAJ-876 Small molecule 200 mg Oral
Comparator TBAJ-876 Small molecule 400 mg Oral
Comparator TBAJ-876 Small molecule 800 mg Oral

Indications

lung disorder multidrug-resistant tuberculosis pulmonary tuberculosis