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

30 Technology

Status and phase: Enrolling; Phase 2

Conditions: Pulmonary Tuberculoses

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07073638

RESP30TB-EBA

Details and patient eligibility

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

Full 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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

RESP30TB

Experimental group

Description:

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

Treatment:

Drug: RESP30TB

RESP30TB + HRZE

Experimental group

Description:

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

Treatment:

Drug: RESP30TB

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