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

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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

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

Trial contacts and locations

7

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Central trial contact

Medical Monitor

Data sourced from clinicaltrials.gov

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