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Cystic fibrosis drug trial halted early

NCT ID NCT04375514

Disease control Sponsor: Arrowhead Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called ARO-ENaC in healthy volunteers and people with cystic fibrosis. The goal was to see if it is safe and helps lung function. The trial was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

43 people

The number who actually took part.

Started

Jul 2020

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception * Willing to provide written informed consent and to comply with study requirements * Normal electrocardiogram (ECG) at Screening * Non-smoking * Normal pulmonary function tests at Screening (NHVs only) * No abnormal finding of clinical relevance at Screening other than CF for CF patients * Confirmed diagnosis of CF based on source verifiable medical record (CF patients only) * All other treatments for CF have been stable for at least 2 months and patient is willing to continue this treatment regimen without change for duration of study (CF patients only) Exclusion Criteria: * Acute lower respiratory infection within 30 days of Screening (NHVs only) * History of asthma (specifically, those subjects at risk of bronchial hyperactivity), anaphylaxis or airway hyper-reactivity * Clinically significant history of hyperkalemia or presence of hyperkalemia at Screening * Clinically significant health concerns (other than CF in CF patients) * Human Immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV) * Uncontrolled hypertension * Excessive use of alcohol within one month prior to Screening * Use of illicit drugs within 1 year prior to Screening * Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study * CF exacerbation within 30 days of Dosing (CF patients) * History of solid organ transplant (CF patients) * Diagnosis of hepatic cirrhosis (CF patients) Note: additional inclusion/exclusion criteria may apply per protocol

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis, pulmonary

Contacts and locations

Locations

  • Research Site 1

    Nedlands, Washington, 6009, Australia

  • Research Site 2

    Hamilton, 3204, Australia

  • Research Site 3

    Chermside, Queensland, 4032, Australia

  • Research Site 4

    South Brisbane, Queensland, 4101, Australia

  • Research Site 6

    Grafton, Auckland, 1010, New Zealand

  • Research Site 7

    Dunedin, 9054, New Zealand

  • Research Site 8

    Christchurch, 8140, New Zealand

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