Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis

• Status: Recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thirty Respiratory Limited

Criteria

Inclusion Criteria:

• 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 Criteria:

• HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)

• 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

• 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