Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis

Launched by ARROWHEAD PHARMACEUTICALS · Sep 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new inhalation treatment called ARO-MMP7 for people with a lung condition known as idiopathic pulmonary fibrosis (IPF), as well as for healthy volunteers. The main goal is to check how safe the treatment is, how well it works, and how the body processes it. Initially, healthy participants will take a single dose of the medication, and once safety is confirmed, they will receive multiple doses. Individuals with IPF who are stable and aged 45 or older may also join the study if they meet certain health criteria.

Participants can expect to undergo some health assessments, including lung function tests and possibly a bronchoscopy, to ensure they are suitable for the trial. Both healthy individuals and those with IPF cannot be pregnant or breastfeeding and must agree to use effective birth control during the study. It's important to note that people with recent respiratory infections, certain chronic health conditions, or who have recently used other treatments may not qualify for the study. This trial is currently recruiting participants, and anyone interested should consult with a healthcare provider for more details.

Gender

ALL

Eligibility 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