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

NCT05010577 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-07-18

No results posted yet for this study

Summary

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

Interventions

DRUG

BX004-A

Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa

DRUG

Placebo

Nebulized placebo

Sponsors & Collaborators

  • BiomX, Inc.

    lead INDUSTRY

Principal Investigators

  • Urania Rappo, MD · BiomX, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2024-03-10
Completion
2024-03-10
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Israel
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05010577 on ClinicalTrials.gov