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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05537025
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arrowhead Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Denmark, New Zealand, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: ARO-MMP7

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

Placebo Comparator: Placebo

single or multiple doses of placebo by inhalation of nebulized solution

Interventions

Drug: - ARO-MMP7 Inhalation Solution

ARO-MMP7 by inhalation of nebulized solution

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Odense University Hospital, Odense, Denmark

Status

Recruiting

Address

Odense University Hospital

Odense, ,

Site Contact

Stephanie Paag Svane

Stephanie.Paag.Svane@rsyd.dk

+4521450145

New Zealand Clinical Research, Auckland, New Zealand

Status

Recruiting

Address

New Zealand Clinical Research

Auckland, , 1010

Site Contact

Taisha Stowers

Taisha.Stowers@nzcr.co.nz

+64 9 373 3479

Christchurch, New Zealand

Status

Recruiting

Address

New Zealand Clinical Research-Christchurch

Christchurch, , 08011

Site Contact

Isabelle Van Hout

Isabelle.vanhout@nzcr.co.nz

+64 3 372 9477

Giromed Institute - Barcelona, Barcelona, Spain

Status

Recruiting

Address

Giromed Institute - Barcelona

Barcelona, , 08017

Site Contact

Elisabet Arboix Alamo

elisabet.arboix@giromedinstitute.com

34972183397