study of aro-mmp7 inhalation solution in healthy subjects and patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

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 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