NCT07525427 Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis
| NCT ID | NCT07525427 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gates Medical Research Institute |
| Condition | Drug Susceptible Pulmonary Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2026-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2026-04-14 with a primary completion date of 2026-11-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Gates MRI
STUDY DIRECTOR
Gates Medical Research Institute
Frequently Asked Questions
Who can join the NCT07525427 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Drug Susceptible Pulmonary Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07525427 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07525427 currently recruiting?
Yes, NCT07525427 is actively recruiting participants. Contact the research team at clinical.trials@gatesmri.org for enrollment information.
Where is the NCT07525427 trial being conducted?
This trial is being conducted at Durban, South Africa, George, South Africa, Johannesburg, South Africa, Tembisa, South Africa and 9 additional locations.
Who is sponsoring the NCT07525427 clinical trial?
NCT07525427 is sponsored by Gates Medical Research Institute. The principal investigator is Gates MRI at Gates Medical Research Institute. The trial plans to enroll 150 participants.