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

NCT ID: NCT05537025

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2025-09-05

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ARO-MMP7

single or multiple doses of ARO-MMP7 by inhalation of nebulized solution

Group Type: EXPERIMENTAL

ARO-MMP7 Inhalation Solution

Intervention Type: DRUG

ARO-MMP7 by inhalation of nebulized solution

Placebo

single or multiple doses of placebo by inhalation of nebulized solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Calculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution

Interventions

ARO-MMP7 Inhalation Solution

ARO-MMP7 by inhalation of nebulized solution

Intervention Type: DRUG

Placebo

Calculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site 1

Copenhagen, , Denmark

Research Site 2

Odense, , Denmark

Research Site 1

Ancona, , Italy

Research Site 2

Florence, , Italy

Research Site 3

Milan, , Italy

Research Site 4

Milan, , Italy

Research Site 5

Milan, , Italy

Research Site 1

Auckland, , New Zealand

Research Site 2

Christchurch, , New Zealand

Research Site 2

Seoul, , South Korea

Research Site 3

Soeul, , South Korea

Research Site 1

Ulsan, , South Korea

Research Site 3

Santander, Cantabria, Spain

Research Site 1

Barcelona, , Spain

Research Site 2

Oviedo, , Spain

Research Site 1

Birmingham, , United Kingdom

Research Site 2

Edinburgh, , United Kingdom

Research Site 4

Manchester, , United Kingdom

Research Site 3

Manchester, , United Kingdom

Countries

Denmark; Italy; New Zealand; South Korea; Spain; United Kingdom

Other Identifiers

2023-504964-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AROMMP7-1001

Identifier Type: -

Identifier Source: org_study_id