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

Arrowhead Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: ARO-MMP7 Inhalation Solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05537025

AROMMP7-1001

2023-504964-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 97 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 2 patient groups, including a placebo group

ARO-MMP7

Experimental group

Description:

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

Treatment:

Drug: ARO-MMP7 Inhalation Solution

Placebo

Placebo Comparator group

Description:

single or multiple doses of placebo by inhalation of nebulized solution

Treatment:

Drug: Placebo