NCT07073638

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Thirty Respiratory Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	RESP30TB	Nitric Oxide agent
DRUG	HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)	isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)

Timeline

• Start date: 2025-10-13
• Primary completion: 2026-09-15
• Completion: 2026-11-15
• First posted: 2025-07-18
• Last updated: 2026-01-12

Locations

1 site across 1 country: South Africa