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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504964-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARO-MMP7 | Experimental | single or multiple doses of ARO-MMP7 by inhalation of nebulized solution |
|
| Placebo | Placebo Comparator | single or multiple doses of placebo by inhalation of nebulized solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARO-MMP7 Inhalation Solution | Drug | ARO-MMP7 by inhalation of nebulized solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria (NHVs):
Inclusion Criteria (IPF Participants):
Exclusion Criteria (NHVs):
Exclusion Criteria (IPF Participants):
Note: additional inclusion/exclusion criteria may apply per protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 1 | Copenhagen | DA-2100 | Denmark | |||
| Research Site 2 |
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| Placebo |
| Drug |
Calculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution |
|
| 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: 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: 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: 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 |
| 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 |
| Odense |
| DK-5000 |
| Denmark |
| Research Site 1 | Ancona | 60126 | Italy |
| Research Site 2 | Florence | 50134 | Italy |
| Research Site 3 | Milan | 20122 | Italy |
| Research Site 4 | Milan | 20122 | Italy |
| Research Site 5 | Milan | 20123 | Italy |
| Research Site 1 | Auckland | 1010 | New Zealand |
| Research Site 2 | Christchurch | 08011 | New Zealand |
| Research Site 2 | Seoul | 05505 | South Korea |
| Research Site 3 | Soeul | 21565 | South Korea |
| Research Site 1 | Ulsan | 44033 | South Korea |
| Research Site 3 | Santander | Cantabria | 39008 | Spain |
| Research Site 1 | Barcelona | 08017 | Spain |
| Research Site 2 | Oviedo | 33011 | Spain |
| Research Site 1 | Birmingham | B15 2GW | United Kingdom |
| Research Site 2 | Edinburgh | EH16 4SA | United Kingdom |
| Research Site 4 | Manchester | M23 9QZ | United Kingdom |
| Research Site 3 | Manchester | M8 5RB | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2026 | Jun 29, 2026 | 24 |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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