Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
Purpose
This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with chronic PsA pulmonary infection.
Conditions
- Chronic Pseudomonas Aeruginosa Infection
- Cystic Fibrosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications - Age ≥ 18 years - FEV1 ≥ 40% predicted - Clinically stable lung disease - Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.
Exclusion Criteria
- Known hypersensitivity to bacteriophages or excipients in the formulation. - Receipt of prior bacteriophage therapy within the 6 months prior to Screening - Recovery of Burkholderia species from respiratory tract within 1 year prior to screening - Currently receiving treatment for allergic bronchopulmonary aspergillosis - Currently receiving treatment for active infection with non-tuberculous mycobacteria - History of severe neutropenia - History of lung transplant - History of solid organ transplant - Acquired or primary immunodeficiency syndrome - Initiation or change in CF modulator therapy less than 3 months prior to screening - Pregnant or breastfeeding female
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental BX004-A |
Participants will be randomized to receive standard dose of nebulized bacteriophage |
|
Placebo Comparator Placebo |
Participants will be randomized to receive nebulized placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT05010577
- Status
- Active, not recruiting
- Sponsor
- BiomX, Inc.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and tolerability of BX004-A in CF subjects with chronic PsA pulmonary infection. The study is divided into two parts, a single-ascending and multiple-dose phase (Part 1) and a multiple dose phase (Part 2). Subjects in both parts will be included in a 6-month safety follow-up. A Data Safety Monitoring Board will monitor safety in both parts. The purpose of the study is to evaluate safety and tolerability of BX004-A, and whether BX004-A reduces the PsA burden in the sputum of CF subjects with chronic PsA pulmonary infection. Clinically stable CF subjects with a confirmed diagnosis of CF and chronic PsA pulmonary infection will be enrolled.