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

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