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

NCT ID: NCT07073638

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2026-11-15

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).

Conditions

Pulmonary Tuberculoses

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RESP30TB

Stage 1 - Inhaled RESP30TB 6ml via nebulisation three times daily

Group Type: EXPERIMENTAL

RESP30TB

Intervention Type: DRUG

Nitric Oxide agent

RESP30TB + HRZE

Stage 2 - Inhaled RESP30TB 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily

Group Type: EXPERIMENTAL

RESP30TB

Intervention Type: DRUG

Nitric Oxide agent

HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)

Intervention Type: DRUG

isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)

Interventions

RESP30TB

Nitric Oxide agent

Intervention Type: DRUG

HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)

isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thirty Respiratory Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TASK Clinical Research Centre

Cape Town, Bellville, South Africa

Site Status: RECRUITING

Countries

South Africa

Facility Contacts

Lukhanyile Ketelo

Role: primary

l.ketelo@taskclinical.com

+27 21 917 1044

Other Identifiers

RESP30TB-EBA

Identifier Type: -

Identifier Source: org_study_id