Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis

This is a single-centre, open-label, single arm, clinical trial in two sequential stages, with no stratification. 12 patients will be enrolled in Stage 1, and a further 12 patients will be enrolled in Stage 2 (total of 24 patients in the trial).

Inclusion criteria

• Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial procedures.
• Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
• Newly diagnosed pulmonary TB.
• Rifampicin susceptible pulmonary TB as determined by molecular testing.
• Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more).
• Spirometry performed during screening with a Forced Expiration Volume in the first second (FEV1) of ≥ 40%.
• Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4.

Exclusion criteria

• HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)
• Baseline Methaemoglobin saturation (SpMet) >3%.
• Female patients who is pregnant or breast-feeding.
• Patients planning to conceive a child within the anticipated period of trial participation and for at least 90 days after the last dose of IMP in the trial.
• Participation in other clinical studies with investigational agents within 8 weeks prior to screening.
• Treatment received for this episode of TB with any drug active against M.tb
• Treatment with immunosuppressive medications such as TNF-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening.
• Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.