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

NCT05537025 | Completed Phase 1 Results 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)

  An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Day 1 up to Day 85

Secondary Outcomes (15)

• Change From Baseline to the End of Study (EOS) in Forced Expiratory Volume in One Second (FEV1)

  Baseline, EOS (up to Day 85)

• Change From Baseline to the EOS in Forced Vital Capacity (FVC)

  Baseline, EOS (up to Day 85)

• Change From Baseline to the EOS in Diffusing Capacity for Carbon Monoxide (DLCO)

  Baseline, EOS (up to Day 85)

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

  Pre-dose (Day 1) up to 168 hours post-dose (Day 8)

• MAD Cohorts: Cmax of ARO-MMP7

  Pre-dose up to 6 hours post-dose on Days 1, 15, and 29

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 coronavirus disease (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

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Arrowhead Pharmaceuticals, Inc.

info@arrowheadpharma.com

1 (626) 304-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 5, 2026
• Results First Posted: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

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