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CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)

NCT04684641 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-11-18

Study results available
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Summary

This is a Phase 2 study with primary objective of looking whether YPT-01 phage therapy reduces sputum bacterial load in cystic fibrosis subjects with Pseudomonas aeruginosa.

In addition, study evaluates the safety profile of phage therapy in this patient population.

Conditions

Interventions

DRUG

Standard Dose YPT-01

Participants will be randomized to receive the standard dose of phage therapy YPT-01.

OTHER

Placebo

Participants will be randomized to receive the placebo.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Jonathan Koff, MD · Yale University

  • Benjamin Chan, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2023-05-26
Completion
2023-06-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04684641 on ClinicalTrials.gov