Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
Reason given: Decision was made by the sponsor not to progress to Stage 2
Key facts
- Where
- Cape Town, South AfricaSee the site
- Phase
- Phase 2
Where in South Africa
- TASK Clinical Research CentreCape Town, South AfricaNo longer taking part
Trial details
- Who runs it
- Thirty Respiratory Limited
- Trial code
- NCT06041919
- Record updated
- 15 July 2025
- Original description
A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary TuberculosisRead full original descriptionShow less
A Phase 2 Study to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
Inclusion: Provide written, informed consent prior to all study-related procedures and agree to undergo all study 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 FEV1 of ≥ 40%; Be of non-childbearing potential or willing to use effective methods of contraception.
Exclusion: HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART); 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 nitric oxide and other nitric oxide donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening; Methaemoglobin saturation (SpMet) >3%; Female participant who is pregnant or breast-feeding; Participants planning to conceive a child within the anticipated period of study participation and for at least 90 days after the last dose of IMP in the study.