NCT06526923

A Single Ascending Dose, Phase 1/2 Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of SP-101 Via Nebulizer for the Treatment of Cystic Fibrosis (CF)

Study Summary

This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.

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Interventions

SP-101 and doxorubicin Cohort 1COMBINATION_PRODUCT
Single inhaled dose of SP-101 and doxorubicin Dose 1
SP-101 and doxorubicin Cohort 2COMBINATION_PRODUCT
Single inhaled dose of SP-101 and doxorubicin Dose 2

Study Locations

FacilityCityStateCountry
University of Kansas Medical CenterKansas CityKansasUnited States
Boston Children's Hospital, Brigham & Women's HospitalBostonMassachusettsUnited States
Columbia UniversityNew YorkNew YorkUnited States
Hospital at University of PennsylvaniaPhiladelphiaPennsylvaniaUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026