RecruitingPhase 2NCT06747858
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis
Sponsor
Arcturus Therapeutics, Inc.
Enrollment
12 participants
Start Date
Dec 12, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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
Exclusion Criteria7
- History of illness or medical condition that might pose an additional risk or may confound study results
- Recent moderate or severe hemoptysis
- Recent major surgery
- Solid organ or hematologic transplant
- Requirement of supplemental oxygen while awake or > 2L per minute while sleeping.
- Chronic maintenance systemic corticosteroids exceeding equivalent of daily 15 mg oral prednisone or 30 mg every other day
- Adequate liver and kidney function as determined by lab tests
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Interventions
BIOLOGICALARCT-032
CFTR mRNA formulated in lipid nanoparticles
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06747858
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