ebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas aeruginosa Pulmonary Infectio

Phase 1

• Conditions: Cystic fibrosisChronic Pseudomonas Aeruginosa Infection; MedDRA version: 20.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 22.1Level: LLTClassification code 10082869Term: Chronic Pseudomonas aeruginosa infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-003810-35-CZ
• Lead Sponsor: BiomX Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-19
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
2. Age = 18 years
3. FEV1 = 40% predicted
4. Clinically stable lung disease
5. Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

1. Known hypersensitivity to bacteriophages or excipients in the formulation.
2. Receipt of prior bacteriophage therapy within the 6 months prior to Screening
3. Recovery of Burkholderia species from respiratory tract within 1 year prior to screening
4. Currently receiving treatment for allergic bronchopulmonary aspergillosis
5. Currently receiving treatment for active infection with non-tuberculous mycobacteria
6. History of severe neutropenia
7. History of lung transplant
8. History of solid organ transplant
9. Acquired or primary immunodeficiency syndrome
10. Initiation or change in CF modulator therapy less than 3 months prior to screening
11. Pregnant or breastfeeding female

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of nebulized BX004-A in CF subjects with chronic PsA pulmonary infection.;Secondary Objective: not applicable;Primary end point(s): Safety and tolerability, as assessed by vital sign measurements, pulmonary examination, laboratory tests, spirometry and adverse events;Timepoint(s) of evaluation of this end point: Safety will be assessed at every clinic visit: D1, D2, D3, D4, D8, D15 (also D35 phone call and 6 month phone call)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable