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Safety and effectiveness study of inhaled ARCT-032 (mRNA therapy) in adults with Cystic Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on Cystic Fibrosis, a genetic condition that affects the lungs and other organs. The study will test a new inhaled treatment called ARCT-032, which contains genetic material (mRNA) designed to help produce a protein that is missing or not working properly in people with Cystic Fibrosis. The purpose is to evaluate if this treatment is safe and well-tolerated by patients with this condition.

The treatment will be delivered using a special device called an eFlow Nebulizer System, which turns the liquid medication into a fine mist that can be inhaled into the lungs. This portable, battery-operated device is quiet and lightweight, making it convenient for patients to use. The study will involve multiple doses of the treatment given over time to determine the most appropriate and safe amount.

During the study, participants will receive increasing doses of ARCT-032 through inhalation. This is particularly important for patients who cannot take other available treatments for Cystic Fibrosis or have not responded well to them. The study will monitor how patients respond to the treatment, including any changes in their breathing function and overall health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your eligibility for the study will be evaluated through medical tests and examinations

    The assessment includes lung function tests to confirm your FEV1 (breathing capacity) is between 40% and 100% of predicted value

    Laboratory tests will check your liver function, kidney function, and hemoglobin levels

    An electrocardiogram (ECG) will be performed to check your heart rhythm

  2. Step 2

    Treatment period preparation

    You must not have any respiratory infections or lung problems for a specified period before starting treatment

    If you were previously taking CFTR modulator therapy, you must have stopped it for the required period

    Baseline measurements of your health status will be recorded

  3. Step 3

    Treatment administration

    You will receive ARCT-032, an inhaled medication that contains genetic material (mRNA)

    The medication will be given through inhalation in liquid vapor form

    Multiple doses will be administered during the study period

    Your lung function will be checked before and after each dose to monitor for any breathing difficulties

  4. Step 4

    Monitoring and assessments

    Regular physical examinations and vital sign checks will be performed

    Blood tests will be conducted to measure medication levels

    Your lung function will be regularly tested

    You will complete questionnaires about your respiratory symptoms

    Any side effects or health changes will be recorded and monitored

  5. Step 5

    Study completion

    Final health assessments will be performed

    Follow-up monitoring will continue for 30 days after your last dose

    The study is expected to run until May 2026

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must have a confirmed diagnosis of Cystic Fibrosis documented in medical records with either: - Two CF-causing mutations, or - Sweat chloride value of 60 mmol/L or higher with history of chronic lung and sinus disease
  • Must not be eligible for CFTR modulator therapy (a type of treatment that helps improve the function of the defective protein in CF) or not currently taking these medications
  • Must have lung function test (FEV1 - the amount of air that can be forcefully exhaled in one second) between 40% and 100% of the predicted normal value
  • Must have stable respiratory condition with no recent chest infections or changes in treatment
  • Must have liver function tests less than 3 times the normal limit
  • Must have kidney function (eGFR) greater than 45 L/min/1.73m2
  • Must have hemoglobin (oxygen-carrying protein in blood) level of at least 10 g/dL
  • Must have normal heart rhythm on ECG (heart electrical activity test)
  • For women who can become pregnant: must agree to use effective birth control during the study and for 30 days after the last dose
  • For men with partners who can become pregnant: must agree to have their partner use effective birth control during the study and for 30 days after the last dose
  • Must be willing and able to: - Sign an informed consent form - Follow study procedures - Perform acceptable breathing tests - Complete all study visits

Who cannot join the trial?

13 criteria

  • History of organ transplantation (surgical procedure where an organ is removed from one person and placed in another)
  • Active lung infection or significant worsening of lung symptoms in the past 4 weeks
  • Current smoking or use of tobacco products
  • Known allergic reactions to any medications used in the study
  • Participation in another clinical trial within the past 30 days
  • Presence of any other serious medical condition that could interfere with the study
  • Current pregnancy or breastfeeding
  • Liver problems or abnormal liver function tests
  • History of alcohol abuse or illegal drug use
  • Unable to follow study procedures or attend scheduled visits
  • Taking medications that could interact with the study drug
  • History of mental health conditions that could affect participation in the study
  • Unstable medical conditions that require frequent medication changes
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Investigated drugs

ARCT-032 is an investigational therapy being studied for people with Cystic Fibrosis (CF). It is a new treatment that is being evaluated to determine if it is safe and well-tolerated by patients with CF. The medication is being tested in different doses to understand how patients respond to the treatment. This is an experimental therapy that aims to help people with Cystic Fibrosis, but its effectiveness and safety are still being studied through this clinical trial.

What is already known about the treatment

ARCT-032 – An investigational therapeutic agent currently undergoing Phase 2 clinical trials for the treatment of Cystic Fibrosis (CF). This medication represents a novel approach to CF treatment, though its specific form of administration is not yet publicly disclosed in the clinical documentation. The primary objective of the ongoing clinical trials is to evaluate the safety and tolerability of multiple ascending doses in patients with CF, suggesting a carefully monitored dose-escalation study design. While the exact molecular mechanism of action is not specified in the available trial data, this experimental therapy is being studied as a potential intervention for managing CF symptoms and possibly addressing the underlying disease mechanisms.

Investigated diseases

Cystic Fibrosis – A genetic disorder that affects cells producing mucus, sweat, and digestive fluids. The condition causes these fluids to become thick and sticky instead of thin and slippery. This buildup of thick, sticky secretions can affect various organs, particularly the lungs and digestive system. In the lungs, the thick mucus clogs the airways and traps bacteria, leading to frequent infections and breathing problems. The condition also affects the pancreas, limiting the body's ability to break down and absorb nutrients from food. People with cystic fibrosis often experience persistent coughing, recurring chest infections, and digestive difficulties. The disease is present from birth and is inherited in an autosomal recessive pattern.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517663-23-01Protocol codeARCT-032-02Estimated enrolment30 patientsSponsorArcturus Therapeutics Europe B.V.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).