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RecruitingPhase 2

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

Arcturus Therapeutics, Inc. · NCT06747858

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
33
US sites recruiting
11
Study start
December 12, 2024
Record last updated
May 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ARCT-032

Conditions: Cystic Fibrosis; CFTR Gene Mutation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Recruiting US locations

Study contacts (from the official record)

  • Clinical Trial Disclosure Manager Central Email Box · 858-900-2660 · CFclinicaltrials@arcturusrx.com
Safety, Tolerability and Efficacy Study of ARCT-032 in People With… (NCT06747858) | Bored Studies