Trial

A Phase 2a, Dose Escalation, Controlled, Randomized Study to Evaluate Safety, Early Bactericidal Activity (EBA) and Pharmacokinetics of TBA-7371 in Adult Patients With Rifampicin-sensitive Pulmonary Tuberculosis

Study Director
Start Date
1 / 2020
Trial Phase
Trial Status
enrolling
Current Enrollment
Target Enrollment
90
Overview
Arm  Intervention/treatment 
Experimental: TBA-7371 100 mg QD Drug: TBA-7371

Participants will receive TBA-7371 oral suspension 100 milligram (mg) once daily (QD) for 14 days.
Experimental: TBA-7371 100 mg BID Drug: TBA-7371

Participants will receive TBA-7371 oral suspension 100 mg twice daily (BID) for 14 days.
Experimental: TBA-7371 200 mg QD Drug: TBA-7371

Participants will receive TBA-7371 oral suspension 200 mg QD for 14 days.
Experimental: TBA-7371 100 mg TID Drug: TBA-7371

Participants will receive TBA-7371 oral suspension 100 mg three times daily (TID) for 14 days.
Experimental: TBA-7371 400 mg QD Drug: TBA-7371

Participants will receive TBA-7371 oral suspension 400 mg QD for 14 days.
Active Comparator: HRZE Drug: HRZE

Participants will receive Isoniazid [H] / rifampicin [R] / pyrazinamide [Z] / ethambutol [E] (HRZE), a fixed dose combination (H: 75 mg / R: 150 mg / Z: 400 mg / E: 275 mg) tablet QD for 14 days.

Other Name: Rifafour® e-275
Registry Link
Developer Associations
Bill & Melinda Gates Foundation
Compound Associations
TBA-7371