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Study With Phage for CF Subjects With Pseudomonas Lung Infection

NCT06998043 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-07-22

No results posted yet for this study

Summary

The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).

Conditions

  • Chronic Pseudomonas Aeruginosa Infection
  • Cystic Fibrosis (CF)

Interventions

BIOLOGICAL

BX004

Bacteriophage

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • BiomX Ltd

    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
2025-07-02
Primary Completion
2026-03-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06998043 on ClinicalTrials.gov