Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
NCT ID: NCT06747858
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
12 participants
INTERVENTIONAL
2024-12-12
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Dose Level A of ARCT-032, inhaled daily for 28 days
ARCT-032
CFTR mRNA formulated in lipid nanoparticles
Cohort 2
Dose Level B of ARCT-032, inhaled daily for 28 days
ARCT-032
CFTR mRNA formulated in lipid nanoparticles
Cohort 3
Dose Level C of ARCT-032, inhaled daily for 28 days
ARCT-032
CFTR mRNA formulated in lipid nanoparticles
Interventions
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ARCT-032
CFTR mRNA formulated in lipid nanoparticles
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. FEV1 between 40% and 100% of predicted value
Exclusion Criteria
2. Recent moderate or severe hemoptysis
3. Recent major surgery
4. Solid organ or hematologic transplant
5. Requirement of supplemental oxygen while awake or \> 2L per minute while sleeping.
6. Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day
7. Adequate liver and kidney function as determined by lab tests
18 Years
ALL
No
Sponsors
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Arcturus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Arizona
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
The Cystic Fibrosis Institute
Northfield, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Vanderbilt University
Nashville, Tennessee, United States
UT Health
San Antonio, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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ARCT-032-02
Identifier Type: -
Identifier Source: org_study_id
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