A Phase 2, Open-Label, Multi-Group, Controlled, Randomized Trial of the Safety, Bactericidal Activity, and Pharmacokinetics of TBD09 in Combination With Other Active Agents in Adults With Drug-Sensitive Pulmonary Tuberculosis
Sponsor study identifier
interventional
150
1 country
13
Study Start
April 14, 2026
Actual (reported)Primary Completion
November 5, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 5, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 5, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2026
Actual (reported)April 13, 2026
Actual (reported)April 14, 2026
Actual (reported)November 5, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 5, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Bactericidal Activity
Average daily change in MGIT sputum culture TTD from baseline to end-of-treatment (EOT)
From randomization through Day 28 (EOT)
Safety: SAEs
Proportion of participants with this event
Screening through Day 35 (EOS)
Safety: TEAEs
Proportion of participants with this event
Screening through Day 35 (EOS)
Safety: AESIs
Proportion of participants with this event
Screening through Day 35 (EOS)
Safety: Hematologic Effect
Randomization through Day 35 (EOS)
Safety: Visual Acuity Assessment
Randomization through Day 35 (EOS)
Safety: Colour Vision Assessment
Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Randomization through Day 35 (EOS)
The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline and pretomanid
The combination of TBD09 (100 mg QD), bedaquiline and pretomanid
The combination of TBD09 (300 mg QD), bedaquiline and pretomanid
Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days
Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Bedaquiline, pretomanid and TBD09
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Bedaquiline, pretomanid and TBD09
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Bedaquiline, pretomanid and TBD09
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Bedaquiline, pretomanid and TBD09
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Bedaquiline, pretomanid and linezolid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordEnhancing Care Foundation at Wentworth Hospital
Durban, Bluff, 4052, South Africa
TASK Applied Science - Eden
George, Central, 6529, South Africa
Gates MRI
Gates Medical Research Institute
First Submitted
April 1, 2026
First Posted
April 13, 2026
Study Start
April 14, 2026
Actual (reported)Primary Completion
November 5, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Safety: AEs leading to treatment discontinuation
Proportion of participants with this event
Screening through Day 35 (EOS)
The combination of TBD09 (500 mg QD), bedaquiline and pretomanid
The combination of linezolid (600 mg QD), bedaquiline and pretomanid
Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Linked from the registry description. Each source intervention is retained as reported.
In: Bedaquiline, pretomanid and linezolid
In: Bedaquiline, pretomanid and linezolid
In: Bedaquiline, pretomanid and linezolid
Contact the study team to confirm eligibility.
Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital
Johannesburg, Gauteng, 2092, South Africa
The Aurum Institute Tembisa
Tembisa, Gauteng, 1736, South Africa
CHRU @ Isango Lethemba
Bethelsdorp, Gqeberha, 6003, South Africa
Madibeng Centre for Research
Brits, North West, 0250, South Africa
Setshaba Research Center
Pretoria, Soshangue, 0152, South Africa
ONE MRI
Cape Town, Western Cape, 7405, South Africa
TASK Applied Science - Brookylyn Chest Hospital
Cape Town, Western Cape, 7405, South Africa
BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital
Cape Town, Western Cape, 7505, South Africa
UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)
Cape Town, Western Cape, 7700, South Africa
Desmond Tutu Health Foundation
Cape Town, Western Cape, 7750, South Africa
Synergy Biomedical Research Institute (SBRI)
East London, 5241, South Africa
Study Completion
November 5, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 30, 2026
Record last verified: 2026-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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