Safety, Tolerability and Efficacy Study of ARCT-032 in People with Cystic Fibrosis

Description

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.

Conditions

Cystic Fibrosis, CFTR Gene Mutation

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Study Overview

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Study Details

Study overview

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.

A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People with Cystic Fibrosis

Safety, Tolerability and Efficacy Study of ARCT-032 in People with Cystic Fibrosis

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Northfield

The Cystic Fibrosis Institute, Northfield, Illinois, United States, 60093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Confirmed diagnosis of Cystic Fibrosis
  • 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
  • 1. History of illness or medical condition that might pose an additional risk or may confound study results
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arcturus Therapeutics, Inc.,

Study Record Dates

2025-12