Idiopathic Pulmonary FibrosisPhase 1/2NCT05537025
Study of ARO-MMP7 Inhalation Solution in Healthy Participants and Participants With Idiopathic Pulmonary Fibrosis
A Phase 1/2 study testing ARO-MMP7 Inhalation Solution in people with Idiopathic Pulmonary Fibrosis, run by Arrowhead Pharmaceuticals at 19 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- ARO-MMP7 Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 19 sitesin 6 countries
- Study dates
- 30 Jan 2023to 5 Sep 2025
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
19 sites in 6 countries.
19 sites in 6 countries
Italy5 sites
Research Site 1
Ancona, 60126
Research Site 2
Florence, 50134
Research Site 3
Milan, 20122
Research Site 4
Milan, 20122
Research Site 5
Milan, 20123
United Kingdom4 sites
Research Site 1
Birmingham, B15 2GW
Research Site 2
Edinburgh, EH16 4SA
Research Site 4
Manchester, M23 9QZ
Research Site 3
Manchester, M8 5RB
South Korea3 sites
Research Site 2
Seoul, 05505
Research Site 3
Soeul, 21565
Research Site 1
Ulsan, 44033
Spain3 sites
Research Site 1
Barcelona, 08017
Research Site 2
Oviedo, 33011
Research Site 3
Santander, Cantabria, 39008
Denmark2 sites
Research Site 1
Copenhagen, DA-2100
Research Site 2
Odense, DK-5000
New Zealand2 sites
Research Site 1
Auckland, 1010
Research Site 2
Christchurch, 08011
About this study
Official title: A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
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
- Being tested
- ARO-MMP7 Inhalation Solution, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-MMP7 Inhalation SolutionDrug
ARO-MMP7 by inhalation of nebulized solution
PlaceboDrug
Calculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution
| Study group | Role | What they receive |
|---|---|---|
| ARO-MMP7 | Experimental | single or multiple doses of ARO-MMP7 by inhalation of nebulized solution Receives: Drug: ARO-MMP7 Inhalation Solution |
| Placebo | Placebo comparator | single or multiple doses of placebo by inhalation of nebulized solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
FEV1 was measured using Spirometry.
Measured: Baseline, EOS (up to Day 85)
Change From Baseline to the EOS in Forced Vital Capacity (FVC)
FVC was measured using Spirometry.
Measured: Baseline, EOS (up to Day 85)
Change From Baseline to the EOS in Diffusing Capacity for Carbon Monoxide (DLCO)
DLCO measures gas diffusion from the alveoli to the blood and is impaired by alveolar filling processes, interstitial lung diseases (ILDs), and emphysema. DLCO was measured in milliliters (mL)/minute (min)/millimeters of mercury (mmHG).
Measured: Baseline, EOS (up to Day 85)
SAD Cohorts: Maximum Observed Plasma Concentration (Cmax) of ARO-MMP7
Measured: Pre-dose (Day 1) up to 168 hours post-dose (Day 8)
MAD Cohorts: Cmax of ARO-MMP7
Measured: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29
IPF Cohorts: Cmax of ARO-MMP7
Measured: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29
SAD Cohorts: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of ARO-MMP7
Measured: Pre-dose up to 24 hours post-dose (Day 2)
MAD Cohorts: AUC0-24 of ARO-MMP7
Measured: Pre-dose up to 24 hours post-dose on Days 1, 15, and 29
IPF Cohorts: AUC0-24 of ARO-MMP7
Measured: Pre-dose up to 24 hours post-dose on Days 1, 15, and 29
SAD Cohorts: Time to Reach Cmax (Tmax) of ARO-MMP7
Measured: Pre-dose (Day 1) up to 168 hours post-dose (Day 8)
MAD Cohorts: Tmax of ARO-MMP7
Measured: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29
IPF Cohorts: Tmax of ARO-MMP7
Measured: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29
Urine PK of ARO-MMP7: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount Excreted; Ae) in NHVs Enrolled in SAD Cohorts
Measured: Pre-dose up to 24 hours post-dose on Day 1
Urine PK of ARO-MMP7: Percentage of Administered Drug Recovered in Urine Over 0 to 24 Hours (Fraction Excreted; fe) in NHVs Enrolled in SAD Cohorts
Measured: Pre-dose up to 24 hours post-dose on Day 1
Urine PK of ARO-MMP7: Renal Clearance (CLr) in NHVs Enrolled in SAD Cohorts
Measured: Pre-dose up to 24 hours post-dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start30 Jan 2023
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537025
- Sponsor's protocol ID
- AROMMP7-1001
- Other IDs
- 2023-504964-41, 2023
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2022
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No