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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05537025




Registration number
NCT05537025
Ethics application status
Date submitted
8/09/2022
Date registered
13/09/2022
Date last updated
25/11/2024

Titles & IDs
Public title
Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
Scientific title
A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
Secondary ID [1] 0 0
2023-504964-41
Secondary ID [2] 0 0
AROMMP7-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARO-MMP7 Inhalation Solution
Treatment: Drugs - Placebo

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

Placebo comparator: Placebo - single or multiple doses of placebo by inhalation of nebulized solution


Treatment: Drugs: ARO-MMP7 Inhalation Solution
ARO-MMP7 by inhalation of nebulized solution

Treatment: Drugs: Placebo
Calculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over Time
Timepoint [1] 0 0
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 [1] 0 0
Change From Baseline Over Time in Forced Expiratory Volume (FEV1)
Timepoint [1] 0 0
Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is = 70% of the baseline value, whichever is later)
Secondary outcome [2] 0 0
Change From Baseline Over Time in Forced Vital Capacity (FVC)
Timepoint [2] 0 0
Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is = 70% of the baseline value, whichever is later)
Secondary outcome [3] 0 0
Change From Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO)
Timepoint [3] 0 0
Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is = 70% of the baseline value, whichever is later)
Secondary outcome [4] 0 0
PK of ARO-MMP7: Maximum Observed Plasma Concentration (Cmax)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to 24 Hours (AUC0-24)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to Infinity (AUCinf)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
PK of ARO-MMP7: Terminal Elimination Half-Life (t1/2)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
PK of ARO-MMP7: Apparent Systemic Clearance (CL/F)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
PK of ARO-MMP7: Apparent Terminal Phase Volume of Distribution (VZ/F)
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
PK of ARO-MMP7: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount excreted; Ae) in NHVs
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
PK of ARO-MMP7: Percentage of Administered Drug Recovered in Urine Over 0 to 24 Hours in NHVs
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
PK of ARO-MMP7: Renal Clearance (CLr) in NHVs
Timepoint [13] 0 0
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
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
97
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
Spain
State/province [5] 0 0
Cantabria
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Oviedo
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Birmingham
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Edinburgh
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arrowhead Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05537025
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Monitor
Address 0 0
Country 0 0
Phone 0 0
626-304-3400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05537025