Bacteriophage Therapy for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: BiomX, Inc.

Trial Summary

What is the purpose of this trial?

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.

Research Team

Urania Rappo, MD

Principal Investigator

BiomX, Inc.

Eligibility Criteria

Adults over 18 with cystic fibrosis and chronic lung infection caused by Pseudomonas aeruginosa can join. They must be clinically stable, able to produce sputum samples, and have a certain level of lung function (FEV1 ≥ 40%). Excluded are those with severe immune issues, prior bacteriophage therapy within six months, specific ongoing treatments for other conditions, or recent changes in CF modulator therapy.

Inclusion Criteria

My lung condition is currently stable.

I am 18 years old or older.

Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.

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Exclusion Criteria

I have had severe low white blood cell counts.

You are allergic to bacteriophages or other ingredients in the medicine.

Pregnant or breastfeeding female

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Treatment Details

Interventions

BX004-A (Virus Therapy)
Placebo (Other)

Trial OverviewThe trial is testing BX004-A, a nebulized bacteriophage therapy against a placebo. The main goal is to check if it's safe and tolerable for patients. Researchers will also explore whether this treatment reduces the amount of Pseudomonas bacteria in the lungs.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BX004-AExperimental Treatment1 Intervention

Participants will be randomized to receive standard dose of nebulized bacteriophage

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive nebulized placebo