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

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.

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