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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05537025
Registration number
NCT05537025
Ethics application status
Date submitted
8/09/2022
Date registered
13/09/2022
Date last updated
30/05/2024
Titles & IDs
Public title
Study of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
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Scientific title
A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
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Secondary ID [1]
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2023-504964-41
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Secondary ID [2]
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AROMMP7-1001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over Time
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Assessment method [1]
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Timepoint [1]
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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)
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Secondary outcome [1]
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Change From Baseline Over Time in Forced Expiratory Volume (FEV1)
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Assessment method [1]
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Timepoint [1]
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Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is = 70% of the baseline value, whichever is later)
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Secondary outcome [2]
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Change From Baseline Over Time in Forced Vital Capacity (FVC)
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Assessment method [2]
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Timepoint [2]
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Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is = 70% of the baseline value, whichever is later)
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Secondary outcome [3]
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Change From Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO)
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Assessment method [3]
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Timepoint [3]
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Baseline through EOS (up to 85 days, or until serum MMP7 protein concentration is = 70% of the baseline value, whichever is later)
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Secondary outcome [4]
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PK of ARO-MMP7: Maximum Observed Plasma Concentration (Cmax)
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Assessment method [4]
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Timepoint [4]
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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
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Secondary outcome [5]
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PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to 24 Hours (AUC0-24)
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Assessment method [5]
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Timepoint [5]
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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
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Secondary outcome [6]
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PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)
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Assessment method [6]
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Timepoint [6]
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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
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Secondary outcome [7]
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PK of ARO-MMP7: Area Under the Plasma Concentration versus Time Curve from Zero to Infinity (AUCinf)
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Assessment method [7]
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Timepoint [7]
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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
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Secondary outcome [8]
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PK of ARO-MMP7: Terminal Elimination Half-Life (t1/2)
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Assessment method [8]
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Timepoint [8]
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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
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Secondary outcome [9]
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PK of ARO-MMP7: Apparent Systemic Clearance (CL/F)
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Assessment method [9]
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Timepoint [9]
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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
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Secondary outcome [10]
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PK of ARO-MMP7: Apparent Terminal Phase Volume of Distribution (VZ/F)
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Assessment method [10]
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Timepoint [10]
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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
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Secondary outcome [11]
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PK of ARO-MMP7: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount excreted; Ae) in NHVs
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Assessment method [11]
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Timepoint [11]
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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
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Secondary outcome [12]
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PK of ARO-MMP7: Percentage of Administered Drug Recovered in Urine Over 0 to 24 Hours in NHVs
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Assessment method [12]
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Timepoint [12]
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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
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Secondary outcome [13]
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PK of ARO-MMP7: Renal Clearance (CLr) in NHVs
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Assessment method [13]
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Timepoint [13]
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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
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2025
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Actual
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Sample size
Target
97
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Denmark
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State/province [1]
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Odense
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Country [3]
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New Zealand
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State/province [3]
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Christchurch
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Country [4]
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Spain
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State/province [4]
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Barcelona
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Country [5]
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United Kingdom
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State/province [5]
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Edinburgh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arrowhead Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05537025
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Medical Monitor
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Address
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Country
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Phone
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626-304-3400
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05537025
Download to PDF