clinical trial · NCT06526923
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
Spirovant Sciences, Inc.·phase2·recruiting·n = 15
Cystic FibrosisSP-101 and doxorubicin Cohort 1SP-101 and doxorubicin Cohort 2
brief 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.
started
Sep 16, 2024
primary completion
Dec 31, 2026
completion
Dec 31, 2026
last updated
Nov 25, 2024
detailed description
This multi-center study is a first-in-human, single ascending dose, Phase 1/2 trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of various dose levels in people with CF who are ineligible or intolerant to CFTR modulator therapy.
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol