Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis

NCT07525427 | Recruiting Phase 2 DMC

• 1 other identifier: Gates MRI-TBD09-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Drug Susceptible Pulmonary Tuberculosis

Keywords

TBD09; oxazolidinone; bedaquiline; pretomanid; linezolid; drug-susceptible pulmonary tuberculosis

Outcome Measures

Primary Outcomes (5)

• 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: AEs leading to treatment discontinuation

  Proportion of participants with this event

  Screening through Day 35 (EOS)

Secondary Outcomes (13)

• 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)

Study Arms (5)

Group 1

EXPERIMENTAL

The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline and pretomanid

Drug: Bedaquiline, pretomanid and TBD09

Group 2

EXPERIMENTAL

The combination of TBD09 (100 mg QD), bedaquiline and pretomanid

Drug: Bedaquiline, pretomanid and TBD09

Group 3

EXPERIMENTAL

The combination of TBD09 (300 mg QD), bedaquiline and pretomanid

Drug: Bedaquiline, pretomanid and TBD09

Group 4

EXPERIMENTAL

The combination of TBD09 (500 mg QD), bedaquiline and pretomanid

Drug: Bedaquiline, pretomanid and TBD09

Group 5

ACTIVE COMPARATOR

The combination of linezolid (600 mg QD), bedaquiline and pretomanid

Drug: Bedaquiline, pretomanid and linezolid

Interventions

Bedaquiline, pretomanid and TBD09 DRUG

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 1

Bedaquiline, pretomanid and linezolid DRUG

Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

Group 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years at consent
• Body weight 35-100 kg at screening
• Written informed consent obtained
• Newly diagnosed rifampicin-sensitive pulmonary TB
• Molecular confirmation of M. tuberculosis on Xpert MTB/RIF Ultra
• ≥1+ AFB smear or Xpert Ultra low, medium, or high semi-quantitative result
• Rifampicin sensitivity on molecular test
• Chest X-ray consistent with TB (Investigator assessment)
• Able to spontaneously produce sputum
• Reproductive requirements met
• Women of childbearing potential: 2 approved contraceptive methods or abstinence
• Males: contraception or abstinence through 90 days post-dose

You may not qualify if:

• Prior anti-TB treatment for the current TB episode within 60 days
• Prior medication active against Mtb within 3 months
• Evidence of extra-thoracic TB, per investigator judgement
• Prior treatment completion for TB within 3 years
• or more prior episodes of TB
• Clinically significant history of or current medical condition posing safety risk
• If HIV positive:
• Not on ARVs or taking ARVs for \<3 months prior to screening OR
• CD4+ count \<200cells/uL at screening OR
• HIV viral load \>200 copies /mL at screening OR
• AIDS infection or malignancies
• Meets any of the following laboratory values during screening:
• AST, ALT, or ALP ≥2.5× ULN
• Total bilirubin ≥1.2× ULN
• eGFR \<60 mL/min/1.73 m²

Sponsors & Collaborators

• Gates Medical Research Institute: lead
• IQVIA RDS Inc.: collaborator

Study Sites (13)

Enhancing Care Foundation at Wentworth Hospital

Durban, Bluff, 4052, South Africa

NOT YET RECRUITING

TASK Applied Science - Eden

George, Central, 6529, South Africa

RECRUITING

Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital

Johannesburg, Gauteng, 2092, South Africa

RECRUITING

The Aurum Institute Tembisa

Tembisa, Gauteng, 1736, South Africa

NOT YET RECRUITING

CHRU @ Isango Lethemba

Bethelsdorp, Gqeberha, 6003, South Africa

RECRUITING

Madibeng Centre for Research

Brits, North West, 0250, South Africa

NOT YET RECRUITING

Setshaba Research Center

Pretoria, Soshangue, 0152, South Africa

NOT YET RECRUITING

ONE MRI

Cape Town, Western Cape, 7405, South Africa

RECRUITING

TASK Applied Science - Brookylyn Chest Hospital

Cape Town, Western Cape, 7405, South Africa

RECRUITING

BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital

Cape Town, Western Cape, 7505, South Africa

NOT YET RECRUITING

UCT Lung Institute

Cape Town, Western Cape, 7700, South Africa

NOT YET RECRUITING

Desmond Tutu Health Foundation

Cape Town, Western Cape, 7750, South Africa

NOT YET RECRUITING

Synergy Biomedical Research Institute (SBRI)

East London, 5241, South Africa

RECRUITING

MeSH Terms

Interventions

bedaquiline; pretomanid; Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gates MRI

  Gates Medical Research Institute

  STUDY DIRECTOR

Central Study Contacts

Gates MRI

CONTACT

+1 857 702 2108; clinical.trials@gatesmri.org

Gates MRI

CONTACT

+1-866-789-5757

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): November 5, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 12 months of study completion date
• Access Criteria: Anonymized participant-level data may be shared with the external research in accordance with trial participant' written and executed informed consent and applicable local regulations. Qualified research may submit a request along with a research proposal to Gates MRI for review. A data sharing agreement must be in place before any clinical trial data are shared. Additional restrictions may apply due to contractual obligations or regulatory constraints.

Locations

ZA (13)