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

Prior treatment

• Prior anti-TB treatment for the current TB episode within 60 days
• Prior medication active against Mtb within 3 months
• Prior treatment completion for TB within 3 years
• 2 or more prior episodes of TB
• Current or recent systemic immunosuppressive therapy, including corticosteroids
• Significant drug or alcohol abuse affecting compliance or safety

Other illness

• Clinically significant history of or current medical condition posing safety risk

Lab values

• 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%

Other

• Evidence of extra-thoracic TB, per investigator judgement
• Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment

• 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