Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArcturus Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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% to 100% (cohorts 1-3) and 45% to 90% (cohort 4, inclusive) of predicted value for age, sex and height
Disqualifiers
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
Trial design
Treatments tested in this trial
- ARCT-032
Treatment groups
33 Participants
are divided into 4 treatment groupsLocations
13Arizona
University of Arizona85724, Tucson United States
Arkansas
University of Arkansas for Medical Sciences72205, Little Rock United States
California
Children's Hospital of Los Angeles90027, Los Angeles United States
District of Columbia
Children's National Hospital20010, Washington D.C. United States
Sponsors and collaborators
Arcturus Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov