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

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ClinicalTrials.gov Identifier: NCT05537025
Recruitment Status : Recruiting
First Posted : September 13, 2022
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: ARO-MMP7 Inhalation Solution Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : January 30, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ARO-MMP7
single or multiple doses of ARO-MMP7 by inhalation of nebulized solution
 Drug: ARO-MMP7 Inhalation Solution
ARO-MMP7 by inhalation of nebulized solution
Placebo Comparator: Placebo
single or multiple doses of placebo by inhalation of nebulized solution
 Drug: Placebo
Calculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over Time [ Time Frame: From first dose of study drug through the end of study (EOS; up to 85 days, or until sputum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later) ]

Secondary Outcome Measures :
  1. Change From Baseline Over Time in Forced Expiratory Volume (FEV1) [ Time Frame: Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later) ]
  2. Change From Baseline Over Time in Forced Vital Capacity (FVC) [ Time Frame: Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later) ]
  3. Change From Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO) [ Time Frame: Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later) ]
  4. PK of ARO-MMP7: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30, and (IPF only) Days 8, 22, and 36 ]
  5. PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to 24 Hours (AUC0-24) [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30, and (IPF only) Days 8, 22, and 36 ]
  6. PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast) [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30, and (IPF only) Days 8, 22, and 36 ]
  7. PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to Infinity (AUCinf) [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30, and (IPF only) Days 8, 22, and 36 ]
  8. PK of ARO-MMP7: Terminal Elimination Half-Life (t1/2) [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30, and (IPF only) Days 8, 22, and 36 ]
  9. PK of ARO-MMP7: Apparent Systemic Clearance (CL/F) [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30, and (IPF only) Days 8, 22, and 36 ]
  10. PK of ARO-MMP7: Apparent Terminal Phase Volume of Distribution (VZ/F) [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30, and (IPF only) Days 8, 22, and 36 ]
  11. PK of ARO-MMP7: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount excreted; Ae) in NHVs [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30 ]
  12. PK of ARO-MMP7: Percentage of Administered Drug Recovered in Urine Over 0 to 24 Hours in NHVs [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30 ]
  13. PK of ARO-MMP7: Renal Clearance (CLr) in NHVs [ Time Frame: single dose phase: up to 168 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 15 or 29, 24 hours post-dose on Days 2 and 30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05537025


Contacts
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Contact: Medical Monitor 626-304-3400 AROMMP7@arrowheadpharma.com

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Denmark
Contact: Stephanie Paag Svane    +4521450145    Stephanie.Paag.Svane@rsyd.dk   
Principal Investigator: Ingrid Titlestad, MD         
New Zealand
New Zealand Clinical Research Recruiting
Auckland, New Zealand, 1010
Contact: Taisha Stowers    +64 9 373 3479    Taisha.Stowers@nzcr.co.nz   
Principal Investigator: Mark O'Carroll, MD         
New Zealand Clinical Research-Christchurch Recruiting
Christchurch, New Zealand, 08011
Contact: Isabelle Van Hout    +64 3 372 9477    Isabelle.vanhout@nzcr.co.nz   
Principal Investigator: Alexandra Cole, MD         
Spain
Giromed Institute - Barcelona Recruiting
Barcelona, Spain, 08017
Contact: Elisabet Arboix Alamo    34972183397    elisabet.arboix@giromedinstitute.com   
Principal Investigator: Juan Roldan Sanchez, MD         
Sponsors and Collaborators
Arrowhead Pharmaceuticals
More Information
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05537025    
Other Study ID Numbers: AROMMP7-1001
2023-504964-41 ( EudraCT Number )
First Posted: September 13, 2022    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Respiratory Tract Diseases
Lung Diseases, Interstitial
Lung Diseases