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

NCT05537025 | Completed Phase 1 FDA Drug

• 2 other identifiers: AROMMP7-10012023-504964-41
• Study Type: interventional
• Target: 105
• Locations: 6 countries
• Sites: 19

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over Time

  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 Outcomes (13)

• Change From Baseline Over Time in Forced Expiratory Volume (FEV1)

  Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later)

• Change From Baseline Over Time in Forced Vital Capacity (FVC)

  Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later)

• Change From Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO)

  Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is ≥ 70% of the baseline value, whichever is later)

• PK of ARO-MMP7: Maximum Observed Plasma Concentration (Cmax)

  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

• PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to 24 Hours (AUC0-24)

  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

Study Arms (2)

ARO-MMP7

EXPERIMENTAL

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

Drug: ARO-MMP7 Inhalation Solution

Placebo

PLACEBO COMPARATOR

single or multiple doses of placebo by inhalation of nebulized solution

Drug: Placebo

Interventions

ARO-MMP7 Inhalation Solution DRUG

ARO-MMP7 by inhalation of nebulized solution

ARO-MMP7

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (19)

Research Site 1

Copenhagen, DA-2100, Denmark

Location

Research Site 2

Odense, DK-5000, Denmark

Location

Research Site 1

Ancona, 60126, Italy

Location

Research Site 2

Florence, 50134, Italy

Location

Research Site 3

Milan, 20122, Italy

Location

Research Site 4

Milan, 20122, Italy

Location

Research Site 5

Milan, 20123, Italy

Location

Research Site 1

Auckland, 1010, New Zealand

Location

Research Site 2

Christchurch, 08011, New Zealand

Location

Research Site 2

Seoul, 05505, South Korea

Location

Research Site 3

Soeul, 21565, South Korea

Location

Research Site 1

Ulsan, 44033, South Korea

Location

Research Site 3

Santander, Cantabria, 39008, Spain

Location

Research Site 1

Barcelona, 08017, Spain

Location

Research Site 2

Oviedo, 33011, Spain

Location

Research Site 1

Birmingham, B15 2GW, United Kingdom

Location

Research Site 2

Edinburgh, EH16 4SA, United Kingdom

Location

Research Site 4

Manchester, M23 9QZ, United Kingdom

Location

Research Site 3

Manchester, M8 5RB, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: January 30, 2023
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); NZ (2); IT (5); KR (3); GB (4); ES (3)