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

NCT07073638 | Recruiting Phase 2

• 1 other identifier: RESP30TB-EBA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Tuberculoses

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Inhaled RESP30TB Measured as Number of Treatment Emergent Adverse Events (TEAEs)

  Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death

  Dosing period 14 days + Follow-up period 14 days

Study Arms (2)

RESP30TB

EXPERIMENTAL

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

Drug: RESP30TB

RESP30TB + HRZE

EXPERIMENTAL

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

Drug: RESP30TB; Drug: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)

Interventions

RESP30TB DRUG

Nitric Oxide agent

RESP30TB; RESP30TB + HRZE

HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination) DRUG

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

RESP30TB + HRZE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 Forced Expiration Volume in the first second (FEV1) of ≥ 40%.
• Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4.

You may not qualify if:

• HIV positive AND CD4 \< 350 cells/mm3 OR are receiving antiviral therapy (ART)
• Baseline Methaemoglobin saturation (SpMet) \>3%.
• Female patients who is pregnant or breast-feeding.
• 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.
• 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 NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.

Sponsors & Collaborators

• Thirty Respiratory Limited: lead

Study Sites (1)

TASK Clinical Research Centre

Cape Town, Bellville, 7531, South Africa

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Rifampin; Isoniazid; Pyrazinamide

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Pyrazines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)