A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)

Inclusion criteria

• A new episode of pulmonary TB determined by testing at the study appointed laboratory: Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid molecular test
• A chest X-ray taken no more than 14 days before Screening which in the opinion of the Investigator is consistent with TB
• Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1 pre-treatment sputum sample
• Ability to produce an adequate volume of sputum as determined by an approximately 16-hour overnight sample collection
• Be of non-childbearing potential or using effective methods of birth control, as defined in the protocol

Exclusion criteria

• The patient is mentally or legally incapacitated at Screening
• Any condition or circumstance, in the opinion of the Investigator, which may make the patient unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the patient's safety
• Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator
• The patient has been infected with hepatitis B or C virus as confirmed by tests for hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus antibodies
• The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide, ethambutol or related substances (eg, tosylate), as confirmed by the clinical judgement of the Investigator