A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
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.
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.
Sequential
RESP30TB
DrugNitric Oxide agent
HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)
Drugisoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death
Click on the lead sponsor to view all of their trials.
