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NCT05010577 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by BiomX.

Completed
Registry status
Phase 1
Development phase
43
Enrollment target

NCT05010577: Completed Phase 1 study, sponsored by BiomX.

NCT05010577 is a Phase 1 study that has completed, run by BiomX. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05010577, a Phase 1 study, has completed, sponsored by BiomX.

COMPLETED
Registry status
Phase 1
Development phase
43 participants
Enrollment target

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.

Primary Outcome

Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation

Interventions

  • DRUG Placebo
  • DRUG BX004-A

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2022-06-21
Est. Completion 2024-03-10
Phase Phase 1
BiomX

3 total trials

What the finished NCT05010577 record still lists

NCT05010577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05010577 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05010577 about?

NCT05010577 is a clinical study titled "Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection". 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.

What is the current status of trial NCT05010577?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2022-06-21. Estimated completion is 2024-03-10.

What interventions are being tested in trial NCT05010577?

The interventions under investigation include: Placebo (DRUG), BX004-A (DRUG).

Who is sponsoring clinical trial NCT05010577?

This trial is sponsored by BiomX, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05010577's enrollment target sits among peer trials

43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05010577, the US trial registry maintained by the National Library of Medicine. NCT05010577 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.