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

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 study will initiate with NHVs receiving single ascending doses of ARO-MMP7. Following evaluation of safety and pharmacodynamic (PD) data, participants will receive multiple doses of ARO-MMP7.


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