CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
TBA-7371 +5 moredrug
Likely dose
TBA-7371 100 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04176250
NCT04176250Phase 2Completed
CompareCT.gov

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

Gates Medical Research Institute·interventional·Posted Nov 25, 2019·Updated Apr 11, 2024

In Brief

A Phase 2 clinical trial evaluating TBA-7371 and HRZE for Pulmonary Tuberculosis. Completed, enrolled 93 participants across 4 sites.

Detailed Summary

The purpose of this study is to assess the safety, early bactericidal activity (EBA) and pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and select dose regimen(s) for future studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Tuberculosis
CountriesSouth Africa
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 25, 2019
Enrollment StartJan 16, 2020
Primary CompletionOct 5, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.6 years ago

Interventions

TBA-7371drug

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

TBA-7371drug

Participants will receive TBA-7371 oral suspension 100 mg twice daily (BID) for 14 days.

TBA-7371drug

Participants will receive TBA-7371 oral suspension 200 mg QD for 14 days.

TBA-7371drug

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

TBA-7371drug

Participants will receive TBA-7371 oral suspension 400 mg QD for 14 days.

HRZEdrug

Participants will receive Isoniazid \[H\] / rifampicin \[R\] / pyrazinamide \[Z\] / ethambutol \[E\] (HRZE), a fixed dose combination tablet QD for 14 days, based on weight as 40-54 kilograms (kg): 3 tablets; 55-70 kg: 4 tablets and 71 kg and over: 5 tablets.