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

July 29, 2026 updated by: Gates Medical Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Gates MRI
  • Phone Number: +1-866-789-5757

Study Locations

  • South Africa
      • East London, South Africa, 5241
        • Recruiting
        • Synergy Biomedical Research Institute (SBRI)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mookho Malahleha, MD
    • Bluff
      • Durban, Bluff, South Africa, 4052
        • Recruiting
        • Enhancing Care Foundation at Wentworth Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sundrapragasen (Sandy) Pillay, MD
    • Central
      • George, Central, South Africa, 6529
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2092
        • Recruiting
        • Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammed Rassool, MD
      • Tembisa, Gauteng, South Africa, 1736
    • Gqeberha
      • Bethelsdorp, Gqeberha, South Africa, 6003
    • North West
    • Soshangue
      • Pretoria, Soshangue, South Africa, 0152
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Recruiting
        • TASK Applied Science - Brookylyn Chest Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fairoez Ryklief, MD
      • Cape Town, Western Cape, South Africa, 7505
        • Recruiting
        • BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andriette Hiemstra, MD
      • Cape Town, Western Cape, South Africa, 7700
        • Recruiting
        • UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)
        • Principal Investigator:
          • Rodney Dawson, MD
        • Contact:
        • Contact:
      • Cape Town, Western Cape, South Africa, 7750
      • Cape Town, Western Cape, South Africa, 7405
        • Active, not recruiting
        • ONE MRI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 2 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
    • Hemoglobin <9.0 g/dL (male) or <8.5 g/dL (female)
    • White blood cell count <2,000/mm³
    • Absolute neutrophil count <800/mm³
    • Platelet count ≤100,000/mm³
    • Positive hepatitis B surface antigen
    • Positive hepatitis C antibody
    • HbA1c ≥8.0%
  • Current or recent systemic immunosuppressive therapy, including corticosteroids
  • Significant drug or alcohol abuse affecting compliance or safety
  • Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline and pretomanid
Drug: Bedaquiline, pretomanid and TBD09
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
Drug: Bedaquiline, pretomanid and TBD09
Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Experimental: Group 2
The combination of TBD09 (100 mg QD), bedaquiline and pretomanid
Drug: Bedaquiline, pretomanid and TBD09
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
Drug: Bedaquiline, pretomanid and TBD09
Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Experimental: Group 3
The combination of TBD09 (300 mg QD), bedaquiline and pretomanid
Drug: Bedaquiline, pretomanid and TBD09
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
Drug: Bedaquiline, pretomanid and TBD09
Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Experimental: Group 4
The combination of TBD09 (500 mg QD), bedaquiline and pretomanid
Drug: Bedaquiline, pretomanid and TBD09
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
Drug: Bedaquiline, pretomanid and TBD09
Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Drug: Bedaquiline, pretomanid and TBD09
Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days
Active Comparator: Group 5
The combination of linezolid (600 mg QD), bedaquiline and pretomanid
Drug: Bedaquiline, pretomanid and linezolid
Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bactericidal Activity
Time Frame: From randomization through Day 28 (EOT)
Average daily change in MGIT sputum culture TTD from baseline to end-of-treatment (EOT)
From randomization through Day 28 (EOT)
Safety: SAEs
Time Frame: Screening through Day 35 (EOS)
Proportion of participants with this event
Screening through Day 35 (EOS)
Safety: TEAEs
Time Frame: Screening through Day 35 (EOS)
Proportion of participants with this event
Screening through Day 35 (EOS)
Safety: AESIs
Time Frame: Screening through Day 35 (EOS)
Proportion of participants with this event
Screening through Day 35 (EOS)
Safety: AEs leading to treatment discontinuation
Time Frame: Screening through Day 35 (EOS)
Proportion of participants with this event
Screening through Day 35 (EOS)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety: Hematologic Effect
Time Frame: Randomization through Day 35 (EOS)

Proportion of participants who meet each of the following binary classifications of platelets, absolute neutrophil count (ANC), total white blood cell count (WBC), absolute lymphocyte count (ALC), and hemoglobin:

  1. Post-baseline result < lower limit of normal (LLN) among participants with baseline result > LLN (yes/no)
  2. Post-baseline result < 50% of LLN (yes/no)
  3. Post-baseline result ≥50% decrease relative to baseline (yes/no)
Randomization through Day 35 (EOS)
Safety: Visual Acuity Assessment
Time Frame: Randomization through Day 35 (EOS)
Proportion of participants with worsening of postbaseline visual acuity score of 2 lines or more in either eye using Snellen-type charts
Randomization through Day 35 (EOS)
Safety: Colour Vision Assessment
Time Frame: Randomization through Day 35 (EOS)
Proportion of participants with a new or worsening post-baseline color vision abnormality in either eye (by severity grade) using Ishihara plates
Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Time Frame: Randomization through Day 35 (EOS)
Proportion of participants with a reported new or worsening post-baseline peripheral neuropathy symptom on BPNS in either lower extremity (overall and by severity grade)
Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Time Frame: Randomization through Day 35 (EOS)
Proportion of participants with a new or worsening post-baseline peripheral neuropathy objective physical finding on BPNS in either lower extremity (overall and by severity grade)
Randomization through Day 35 (EOS)
Safety: Brief Peripheral Neuropathy Screen (BPNS) score
Time Frame: Randomization through Day 35 (EOS)
Proportion of participants with new or worsening post-baseline peripheral neuropathy as defined by new/worsening symptom and new/worsening objective physical finding on BPNS in the same lower extremity (overall and by severity grade).
Randomization through Day 35 (EOS)
Bactericidal activity
Time Frame: Day 28 (EOT)
Proportion of participants with negative MGIT sputum cultures at D28
Day 28 (EOT)
Maximum plasma concentration (Cmax) of TBD09
Time Frame: Day 1 and Day 28
Concentrations of TBD09 administered in an investigational combination regimen.
Day 1 and Day 28
Time to maximum plasma concentration (Tmax) of TBD09
Time Frame: Day 1 and Day 28
Concentrations of TBD09 administered in an investigational combination regimen.
Day 1 and Day 28
Area under the curve from 0 to 24 hours (AUC0-24) of plasma concentration of TBD09
Time Frame: Day 1
Concentrations of TBD09 administered in an investigational combination regimen.
Day 1
Area under the curve from 0 to infinity (AUC0-inf) of plasma concentration of TBD09
Time Frame: Day 28
Concentrations of TBD09 administered in an investigational combination regimen.
Day 28
Area under the curve over the dosing interval on day 28 (AUCtau) of plasma concentration of TBD09
Time Frame: Day 28
Concentrations of TBD09 administered in an investigational combination regimen.
Day 28
Accumulation ratio (Area under the curve from 0 to the end of the dosing interval (AUCtau) / AUC0-24), Day 28 vs Day 1 of plasma concentration of TBD09
Time Frame: Day 1 and Day 28
Concentrations of TBD09 administered in an investigational combination regimen.
Day 1 and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gates Medical Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA RDS Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gates MRI, Gates Medical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gates MRI-TBD09-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within 12 months of study completion date

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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