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

Phase 1

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: ARO-MMP7 Inhalation Solution; Drug: Placebo

• Registration Number: NCT05537025
• Lead Sponsor: Arrowhead Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-13
• Study Start: 2023-01-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARO-MMP7	ARO-MMP7 Inhalation Solution	single or multiple doses of ARO-MMP7 by inhalation of nebulized solution
Placebo	Placebo	single or multiple doses of placebo by inhalation of nebulized solution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
PK of ARO-MMP7: Renal Clearance (CLr) in NHVs	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
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 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
PK of ARO-MMP7: Terminal Elimination Half-Life (t1/2)	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: Apparent Systemic Clearance (CL/F)	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 the Last Quantifiable Plasma Concentration (AUClast)	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 Infinity (AUCinf)	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: Apparent Terminal Phase Volume of Distribution (VZ/F)	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: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount excreted; Ae) in NHVs	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
PK of ARO-MMP7: Percentage of Administered Drug Recovered in Urine Over 0 to 24 Hours in NHVs	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

Trial Locations

Locations (15)

Rigshospitalet- University Hosptial of Copenhagen; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Azienda Ospedaliera Ospedali Riuniti; 🇮🇹 Ancona, Italy

AOUC Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Florence, Italy

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

New Zealand Clinical Research; 🇳🇿 Auckland, New Zealand

New Zealand Clinical Research-Christchurch; 🇳🇿 Christchurch, New Zealand

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Giromed Institute - Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

University Hospitals Birmingham NHS Trust; 🇬🇧 Birmingham, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

North Manchester General Hospital; 🇬🇧 Manchester, United Kingdom