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

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

ArmDescriptionAssigned Intervention
Experimental
BX004-A
Participants will be randomized to receive standard dose of nebulized bacteriophage
  • Drug: BX004-A
    Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
    Other names:
    • Bacteriophage
Placebo Comparator
Placebo
Participants will be randomized to receive nebulized placebo
  • Drug: Placebo
    Nebulized placebo
    Other names:
    • Vehicle buffer

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.