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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Show all 11Show fewer

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

Show all 27Show fewer

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.

Country

City, postcode or hospital

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

Other trials in Italy

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

Other trials in United Kingdom

South Korea3 sites

Research Site 2
Seoul, 05505
Research Site 3
Soeul, 21565
Research Site 1
Ulsan, 44033

Other trials in South Korea

Spain3 sites

Research Site 1
Barcelona, 08017
Research Site 2
Oviedo, 33011
Research Site 3
Santander, Cantabria, 39008

Other trials in Spain

Denmark2 sites

Research Site 1
Copenhagen, DA-2100
Research Site 2
Odense, DK-5000

Other trials in Denmark

New Zealand2 sites

Research Site 1
Auckland, 1010
Research Site 2
Christchurch, 08011

Other trials in New Zealand

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

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 groups in NCT05537025
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.

30 Jan 20235 Sep 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT05537025
Acronym / sponsor ID: AROMMP7-1001
Conditions: Idiopathic Pulmonary Fibrosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 30 Jan 2023 (actual)
Primary completion: 5 Sep 2025 (actual)
Study completion: 5 Sep 2025 (actual)
First posted: 13 Sep 2022 (actual)
Results: Posted 5 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ARO-MMP7	Experimental	Drug: ARO-MMP7 Inhalation Solutionsingle or multiple doses of ARO-MMP7 by inhalation of nebulized solution
Placebo	Placebo comparator	Drug: Placebosingle or multiple doses of placebo by inhalation of nebulized solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (27 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ARO-MMP7 Inhalation SolutionARO-MMP7 by inhalation of nebulized solution	Drug	ARO-MMP7
PlaceboCalculated volume of normal saline (0.9% NaCl) to match active treatment by inhalation of nebulized solution	Drug	Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 85
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.

15 secondary outcomes

Change From Baseline to the End of Study (EOS) in Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline, EOS (up to Day 85)
Change From Baseline to the EOS in Forced Vital Capacity (FVC)
Time frame: Baseline, EOS (up to Day 85)
Change From Baseline to the EOS in Diffusing Capacity for Carbon Monoxide (DLCO)
Time frame: Baseline, EOS (up to Day 85)
SAD Cohorts: Maximum Observed Plasma Concentration (Cmax) of ARO-MMP7
Time frame: Pre-dose (Day 1) up to 168 hours post-dose (Day 8)
MAD Cohorts: Cmax of ARO-MMP7
Time frame: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29
IPF Cohorts: Cmax of ARO-MMP7
Time frame: 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
Time frame: Pre-dose up to 24 hours post-dose (Day 2)
MAD Cohorts: AUC0-24 of ARO-MMP7
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 15, and 29
IPF Cohorts: AUC0-24 of ARO-MMP7
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 15, and 29
SAD Cohorts: Time to Reach Cmax (Tmax) of ARO-MMP7
Time frame: Pre-dose (Day 1) up to 168 hours post-dose (Day 8)
MAD Cohorts: Tmax of ARO-MMP7
Time frame: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29
IPF Cohorts: Tmax of ARO-MMP7
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose up to 24 hours post-dose on Day 1

Results and safety

Results posted to the registry on 5 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SAD Cohort: Pooled Placebo	11	11
SAD Cohort: ARO-MMP7 15 mg	6	6
SAD Cohort: ARO-MMP7 32 mg	6	6
SAD Cohort: ARO-MMP7 60 mg	6	6
SAD Cohort: ARO-MMP7 116 mg	10	10
SAD Cohort: ARO-MMP7 224 mg	6	6
MAD Cohort: Pooled Placebo	12	11
MAD Cohort: ARO-MMP7 15 mg	4	4
MAD Cohort: ARO-MMP7 32 mg	5	5
MAD Cohort: ARO-MMP7 60 mg	4	4
MAD Cohort: ARO-MMP7 116 mg	6	6
MAD Cohort: ARO-MMP7 224 mg	6	6
IPF Cohort: Pooled Placebo	6	5
IPF Cohort: ARO-MMP7 116 mg	6	6
IPF Cohort: ARO-MMP7 224 mg	5	5
IPF Cohort: ARO-MMP7 448 mg	6	5

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Day 1 up to Day 85. Count of participants. Unit: Participants

Measure	SAD Cohort: Pooled Placebo n = 11	SAD Cohort: ARO-MMP7 15 mg n = 6	SAD Cohort: ARO-MMP7 32 mg n = 6	SAD Cohort: ARO-MMP7 60 mg n = 6	SAD Cohort: ARO-MMP7 116 mg n = 10	SAD Cohort: ARO-MMP7 224 mg n = 6	MAD Cohort: Pooled Placebo n = 12	MAD Cohort: ARO-MMP7 15 mg n = 4	MAD Cohort: ARO-MMP7 32 mg n = 5	MAD Cohort: ARO-MMP7 60 mg n = 4	MAD Cohort: ARO-MMP7 116 mg n = 6	MAD Cohort: ARO-MMP7 224 mg n = 6	IPF Cohort: Pooled Placebo n = 6	IPF Cohort: ARO-MMP7 116 mg n = 6	IPF Cohort: ARO-MMP7 224 mg n = 5	IPF Cohort: ARO-MMP7 448 mg n = 6
Value	9	5	3	5	10	2	10	3	5	3	3	4	4	4	3	5

Population analysed: Safety Analysis Set included all participants who received at least 1 dose of study drug.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 85. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SAD Cohort: Pooled Placebo	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11
SAD Cohort: ARO-MMP7 15 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
SAD Cohort: ARO-MMP7 32 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
SAD Cohort: ARO-MMP7 60 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
SAD Cohort: ARO-MMP7 116 mg	0 of 10 (0%)	10 of 10 (100%)	0 of 10
SAD Cohort: ARO-MMP7 224 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
MAD Cohort: Pooled Placebo	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
MAD Cohort: ARO-MMP7 15 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
MAD Cohort: ARO-MMP7 32 mg	0 of 5 (0%)	5 of 5 (100%)	0 of 5
MAD Cohort: ARO-MMP7 60 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
MAD Cohort: ARO-MMP7 116 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
MAD Cohort: ARO-MMP7 224 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
IPF Cohort: Pooled Placebo	1 of 6 (16.7%)	4 of 6 (66.7%)	1 of 6
IPF Cohort: ARO-MMP7 116 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
IPF Cohort: ARO-MMP7 224 mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
IPF Cohort: ARO-MMP7 448 mg	2 of 6 (33.3%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Idiopathic Pulmonary Fibrosis

RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

19 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy, United Kingdom, South Korea, Spain, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Day 1 up to Day 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05537025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.