A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Confirmed diagnosis of Cystic Fibrosis
• Not eligible for CFTR modulator therapy, or not taking CFTR modulators for at least 60 days prior to dosing (e.g. due to intolerance, poor response, or lack of access to modulators).
• FEV1 between 40% and 100% of predicted value
Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
University of Arizona
RECRUITING
Tucson
California
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
Florida
Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Central Florida Pulmonary Group
ACTIVE_NOT_RECRUITING
Orlando
Illinois
The Cystic Fibrosis Institute
RECRUITING
Northfield
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Missouri
Washington University
RECRUITING
St Louis
Tennessee
Vanderbilt University
RECRUITING
Nashville
Texas
UT Health
RECRUITING
San Antonio
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Clinical Trial Disclosure Manager Central Email Box
CFclinicaltrials@arcturusrx.com
858-900-2660
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 12
Treatments
Experimental: Cohort 1
Dose Level A of ARCT-032, inhaled daily for 28 days
Experimental: Cohort 2
Dose Level B of ARCT-032, inhaled daily for 28 days
Experimental: Cohort 3
Dose Level C of ARCT-032, inhaled daily for 28 days
Related Therapeutic Areas
Sponsors
Leads: Arcturus Therapeutics, Inc.