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New inhaled therapy targets lung scarring in early trial

NCT ID NCT05537025

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Updated 2 times

Summary

This study tested an inhaled drug called ARO-MMP7 in healthy volunteers and people with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. The main goal was to check safety and how the body handles the drug. About 105 participants took part, receiving either the drug or a placebo via a nebulizer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARO-MMP7 inhalation solution
What this could lead to
If successful, this could point toward a new inhaled treatment to slow or control idiopathic pulmonary fibrosis, a serious lung-scarring disease.
What could go wrong
This is an early phase 1/2a trial focused on safety, so it is too soon to know if it works. The drug may cause side effects or fail to improve lung function.

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

105 people

The number who actually took part.

Started

Jan 2023

Finished

Sep 2025

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 years and older

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 (NHVs): * Normal pulmonary function tests at Screening * Normal electrocardiogram (ECG) at Screening * Non-smoking * Female participants cannot be pregnant or lactating * Male and female participants of childbearing potential must agree to use highly effective contraception and must not donate eggs/sperm during the study and for at least 90 days following end of study or last dose of study drug, whichever is later. Inclusion Criteria (IPF Participants): * Age ≥ 45 years at Screening * Clinical diagnosis consistent with IPF based upon established criteria confirmed by review of high-resolution computed tomography (HRCT) and surgical lung biopsy findings (if available) * Safely able to undergo bronchoscopy * Stable IPF disease at Screening with minimum life expectancy of ≥ 12 months from Screening * Female participants cannot be pregnant or lactating * Male and female participants of childbearing potential must agree to use highly effective contraception and must not donate eggs/sperm during the study and for at least 90 days following end of study or last dose of study drug, whichever is later. Exclusion Criteria (NHVs): * Acute lower respiratory infection within 30 days prior to first dose or acute upper respiratory infection within 7 days prior to first dose * Positive coronavirus disease (COVID-19) test during Screening window * Any history of chronic pulmonary disease or anaphylaxis * Human immunodeficiency virus (HIV) infection, seropositive for hepatitis B virus (HBV), seropositive for hepatitis C virus (HCV) * Uncontrolled hypertension * History of significant cardiac disease * History of major surgery within 12 weeks prior to first dose * Unwilling to limit alcohol consumption to within moderate limits for the duration of the study * Use of illicit drugs * Use of an investigational agent or device within 30 days prior to first dose Exclusion Criteria (IPF Participants): * Interstitial lung disease (ILD) associated with known primary cause * Positive COVID-19 test during Screening window * IPF exacerbation within 6 weeks prior to first dose * Lower respiratory tract infection requiring antibiotics or antivirals within 30 days prior to first dose * Smoking cigarettes or e-cigarettes within 3 months prior to first dose * Use of systemic corticosteroid therapy within 30 days prior to first dose * Initiation or cessation of antifibrotic therapy or change of antifibrotic dose regimen within 10 weeks prior to first dose * Any history of lung transplant or plan to undergo transplant during the course of the study * Any concomitant pulmonary disease that could interfere with the evaluation of the study drug or interpretation of patient safety or study results * HIV infection, seropositive for HBV, seropositive for HCV * Uncontrolled hypertension * History of significant cardiac disease * History of major surgery within 12 weeks prior to first dose * Unwilling to limit alcohol consumption to within moderate limits for the duration of the study * Use of illicit drugs * Use of an investigational agent or device within 30 days prior to first dose Note: additional inclusion/exclusion criteria may apply per protocol

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • Research Site 1

    Copenhagen, DA-2100, Denmark

  • Research Site 1

    Ancona, 60126, Italy

  • Research Site 1

    Auckland, 1010, New Zealand

  • Research Site 1

    Ulsan, 44033, South Korea

  • Research Site 1

    Barcelona, 08017, Spain

  • Research Site 1

    Birmingham, B15 2GW, United Kingdom

  • Research Site 2

    Odense, DK-5000, Denmark

  • Research Site 2

    Florence, 50134, Italy

  • Research Site 2

    Christchurch, 08011, New Zealand

  • Research Site 2

    Seoul, 05505, South Korea

  • Research Site 2

    Oviedo, 33011, Spain

  • Research Site 2

    Edinburgh, EH16 4SA, United Kingdom

  • Research Site 3

    Milan, 20122, Italy

  • Research Site 3

    Soeul, 21565, South Korea

  • Research Site 3

    Santander, Cantabria, 39008, Spain

  • Research Site 3

    Manchester, M8 5RB, United Kingdom

  • Research Site 4

    Milan, 20122, Italy

  • Research Site 4

    Manchester, M23 9QZ, United Kingdom

  • Research Site 5

    Milan, 20123, Italy

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Other studies related to the condition(s) this trial covers.