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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ARO-MMP7 in normal healthy volunteers (NHVs) and in participants with idiopathic pulmonary fibrosis (IPF). The dose level and interval for each IPF participant cohort will be selected by the sponsor based on review of all available safety and PD data.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arrowhead Pharmaceuticals

Criteria

Inclusion Criteria (NHVs):

• Normal pulmonary function tests at Screening, prior to sputum induction

• Normal electrocardiogram (ECG) at Screening

• Non-smoking

• Able to produce an induced sputum sample at 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 12 weeks 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

• Willing to abstain from use of any approved antifibrotic therapy for IPF for the duration of the study

• 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 12 weeks 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-10 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

• Use of antifibrotic therapy for IPF within 10 weeks prior to first dose

• Any history of lung transplant

• 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