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
submitted for publication
Current Enrollment
Target Enrollment
90
Overview

Study completed October 5th, 2022. Results presented at 2023 Union World Conference on Lung Health in Paris. "TBA-7371 was well tolerated and showed significant dose-dependent bactericidal activity with 14 days of treatment in patients with drug-susceptible pulmonary tuberculosis. TBA-7371 could have significant potential in the treatment of TB." Quoted from Bill & Melinda Gates Medical Research Institute LinkedIn Post

 

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

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