Actively Recruiting
Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis
Led by Thirty Respiratory Limited · Updated on 2026-01-12
24
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 tuberculosis.
- Rifampicin susceptible pulmonary tuberculosis as determined by molecular testing.
- Ability to produce an adequate volume of sputum estimated at 10 mL or more from pre-treatment overnight collection.
- Spirometry during screening showing Forced Expiration Volume in 1 second (FEV1) of 40% or more.
- Female participants must be non-childbearing or willing to use effective contraception methods.
You will not qualify if you...
- HIV positive with CD4 count less than 350 cells/mm3 or currently receiving antiviral therapy.
- Baseline methaemoglobin saturation greater than 3%.
- Pregnant or breast-feeding females.
- Planning to conceive a child during the trial and for at least 90 days after last dose.
- Participation in other clinical studies with investigational agents within 8 weeks prior to screening.
- Previous treatment for this tuberculosis episode with any drug active against M.tb.
- Treatment with immunosuppressive medications like TNF-alpha inhibitors within 2 weeks prior to screening or systemic corticosteroids for over 7 days within 2 weeks prior to screening.
- Treatment with nitric oxide, NO donor agents, phosphodiesterase inhibitors, or lung surfactant drugs within 30 days prior to screening.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
TASK Clinical Research Centre
Cape Town, Bellville, South Africa, 7531
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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