Status:
TERMINATED
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
Lead Sponsor:
Thirty Respiratory Limited
Conditions:
Rifampicin Susceptible Pulmonary Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 New...
Detailed Description
A total of approximately 15 participants will be recruited per treatment arm (total of approximately 75 participants in the study). Control arm participants will be split across sequential stages stag...
Eligibility Criteria
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)
- 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
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06041919
Start Date
September 27 2023
End Date
March 6 2025
Last Update
July 15 2025
Active Locations (1)
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1
TASK Clinical Research Centre
Cape Town, Bellville, South Africa, 7531