Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Tuberculoses
• Interventions: Drug: RESP30TB; Drug: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)

• Registration Number: NCT07073638
• Lead Sponsor: Thirty Respiratory Limited

Brief Summary

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

Detailed Description

This is a single-centre, open-label, single arm, clinical trial in two sequential stages, with no stratification. 12 patients will be enrolled in Stage 1, and a further 12 patients will be enrolled in Stage 2 (total of 24 patients in the trial).

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-10-06
• Primary Completion: 2026-09-15
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial procedures.
2. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
3. Newly diagnosed pulmonary TB.
4. Rifampicin susceptible pulmonary TB as determined by molecular testing.
5. Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 mL or more).
6. Spirometry performed during screening with a Forced Expiration Volume in the first second (FEV1) of ≥ 40%.
7. Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4.

Exclusion Criteria

1. HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)
2. Baseline Methaemoglobin saturation (SpMet) >3%.
3. Female patients who is pregnant or breast-feeding.
4. 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.
5. Participation in other clinical studies with investigational agents within 8 weeks prior to screening.
6. Treatment received for this episode of TB with any drug active against M.tb
7. 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.
8. Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RESP30TB	RESP30TB	Stage 1 - Inhaled RESP30TB 6ml via nebulisation three times daily
RESP30TB + HRZE	RESP30TB	Stage 2 - Inhaled RESP30TB 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily
RESP30TB + HRZE	HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)	Stage 2 - Inhaled RESP30TB 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)	Dosing period 14 days + Follow-up period 14 days	Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death

Trial Locations

Locations (1)

TASK Clinical Research Centre; 🇿🇦 Cape town, Bellville, South Africa