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Evaluating ARO-MMP7 Inhalation Solution for Idiopathic Pulmonary Fibrosis

A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis

Phase1; Phase2 Interventional Arrowhead Pharmaceuticals · NCT05537025

This study is testing a new inhalation solution called ARO-MMP7 to see if it is safe and effective for people with idiopathic pulmonary fibrosis.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment97 (estimated)
Ages18 Years and up
SexAll
SponsorArrowhead Pharmaceuticals Industry-sponsored
Locations19 sites (Copenhagen and 18 other locations)
Trial IDNCT05537025 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MMP7 in both healthy volunteers and patients diagnosed with idiopathic pulmonary fibrosis (IPF). Initially, healthy participants will receive single ascending doses of the inhalation solution, followed by multiple doses after assessing safety and pharmacodynamic data. The study aims to gather comprehensive data on how the drug behaves in the body and its effects on lung function.

Who should consider this trial

Good fit: Ideal candidates include adults aged 45 and older with a clinical diagnosis of idiopathic pulmonary fibrosis and stable disease.

Not a fit: Patients with acute exacerbations of IPF or those unable to safely undergo bronchoscopy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with idiopathic pulmonary fibrosis, potentially improving their lung function and quality of life.

How similar studies have performed: Other studies have explored similar inhalation therapies for pulmonary conditions, showing promise, but this specific approach with ARO-MMP7 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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

Where this trial is running

Copenhagen and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.