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Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

B

BiomX

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Cystic Fibrosis
Chronic Pseudomonas Aeruginosa Infection

Treatments

Drug: BX004-A
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05010577
BMX-04-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 2 patient groups, including a placebo group

BX004-A
Experimental group
Description:
Participants will be randomized to receive standard dose of nebulized bacteriophage
Treatment:
Drug: BX004-A
Placebo
Placebo Comparator group
Description:
Participants will be randomized to receive nebulized placebo
Treatment:
Drug: Placebo

Trial contacts and locations

28

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Central trial contact

Physician

Data sourced from clinicaltrials.gov

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