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Study of Combinations of Novel Promising Drugs for Pulmonary Tuberculosis

NCT07773610 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-08-19

No results posted yet for this study

Summary

A phase 2, two-part, multicentre, open label, controlled, randomised clinical trial in adult participants with newly diagnosed, sputum-positive pulmonary drug-sensitive tuberculosis (DSTB). Assessing the Safety and Efficacy of TBAJ-587 as Part of a Combination Regimen in Newly Diagnosed, Drug-Sensitive, Sputum-Positive Pulmonary Tuberculosis

Conditions

  • Tuberculosis, Pulmonary

Interventions

DRUG

TBAJ-587 50 mg

TBAJ-587LD Tablet 50 mg 100 mg OD TBAJ-587HD Tablet 50 mg 200 mg OD TBAJ-587SD Tablet 50 mg Dose selected from Part A daily

DRUG

Pretomanid 200mg

Pretomanid Tablet 200 mg 200 mg OD

DRUG

Linezolid 600Mg Tab

600 mg OD

DRUG

BTZ-043 250 mg or 500 mg

1 000 mg OD

DRUG

HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)

H 75 mg, R 150 mg, Z 400 mg, E 275 mg fixed dose combination

DRUG

Quabodepistat (Q) 30 mg

30 mg OD

DRUG

Ganfeborole 20 mg

20 mg OD

Sponsors & Collaborators

  • TASK Applied Science

    lead OTHER

Principal Investigators

  • Fairoez Ryklief, MBBChB · TASK Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-23
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773610 on ClinicalTrials.gov