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Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease

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ClinicalTrials.gov Identifier: NCT05292950
Recruitment Status : Recruiting
First Posted : March 23, 2022
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.

Condition or disease Intervention/treatment Phase
Asthma Chronic Obstructive Pulmonary Disease Drug: ARO-MUC5AC Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
Actual Study Start Date : June 27, 2022
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
Drug Information available for: Azacitidine

Arms and Interventions
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Arm Intervention/treatment
Experimental: ARO-MUC5AC
ARO-MUC5AC Inhalation
 Drug: ARO-MUC5AC
single or multiple doses of ARO- MUC5AC by inhalation of nebulized solution
Placebo Comparator: Placebo
(0.9% NaCl)
 Drug: Placebo
calculated volume to match active treatment by inhalation of nebulized solution


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: single dose phase: up to Day 29; multiple dose phase: up to Day 85 ]

Secondary Outcome Measures :
  1. Change Over Time from Baseline in Forced Expiratory Volume (FEV1) [ Time Frame: single dose phase: up to Day 29; multiple dose phase: up to Day 85 ]
  2. Change Over Time from Baseline in Forced Vital Capacity (FVC) [ Time Frame: single dose phase: up to Day 29; multiple dose phase: up to Day 85 ]
  3. PK of ARO-MUC5AC: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]
  4. PK of ARO-MUC5AC: Area Under the Plasma Concentration versus Time Curve From Zero to 24 Hours (AUC0-24) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]
  5. PK of ARO-MUC5AC: Area Under the Plasma Concentration versus Time Curve From Zero to the Last Quantifiable Plasma Concentration (AUClast) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]
  6. PK of ARO-MUC5AC: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity (AUCinf) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]
  7. PK of ARO-MUC5AC: Terminal Elimination Half-Life (t1/2) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]
  8. PK of ARO-MUC5AC: Apparent Systemic Clearance (CL/F) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]
  9. PK of ARO-MUC5AC: Apparent Terminal-Phase Volume of Distribution (VZ/F) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]
  10. PK of ARO-MUC5AC: Recovery of Unchanged Drug in Urine Over 24 Hours (Amount Excreted; Ae) [ Time Frame: through 24 hours post-dose ]
  11. PK of ARO-MUC5AC: Percentage of Administered Drug Recovered in Urine Over 0-24 Hours [ Time Frame: through 24 hours post-dose ]
  12. PK of ARO-MUC5AC: Renal Clearance (CLr) [ Time Frame: single dose phase: up to 48 Hours; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs; and up to 6 hours post-dose on Days 1 and 29, and up to 24 hours post-dose on Days 2 and 30 for participants with asthma or COPD ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal pulmonary function tests at Screening (NHVs only)
  • Confirmed diagnosis of asthma or COPD based on source verifiable medical record (asthma and COPD patients only)
  • No abnormal finding of clinical relevance at Screening (NHVs only)
  • Stable dose of asthma controller medications for at least 28 days prior to Screening (asthma patients only)
  • Documented treatment with an inhaled corticosteroid and at least 1 additional maintenance asthma controller medication for at least 3 months prior to Screening (asthma patients only)
  • Non-smoking (NHVs and asthma patients)
  • Current smoker or ex-smoker with smoking history of ≥ 10 pack-years (COPD patients only)
  • All COPD treatments have been stable for at least one month prior to Screening (COPD patients only)
  • Able to produce an induced sputum sample at Screening
  • Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 90 days following the last dose of study drug
  • Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

  • Acute lower respiratory infection within 30 days prior to first dose and/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 (NHVs only)
  • Any concomitant pulmonary disease in asthma or COPD patients that could interfere with the evaluation of the study drug or interpretation of patient safety or study results
  • Use of theophylline within 30 days prior to first dose
  • History of lung volume reduction surgery or pneumonectomy (COPD patients)
  • Need for chronic oxygen support at Screening
  • Clinically significant health concerns (other than asthma in asthma patients)
  • Human immunodeficiency virus (HIV) infection, seropositive for hepatitis B virus (HBV), seropositive for hepatitis C virus (HCV)
  • Uncontrolled hypertension
  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05292950


Contacts
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Contact: Medical Monitor 626-304-3400 AROMUC5AC@arrowheadpharma.com

Locations
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Australia
Institute For Respiratory Health - Perth Recruiting
Nedlands, Australia, 6009
Contact: Meaghan Shorten    +6 151 0944    meagan.shorten@resphealth.uwa.edu.au   
Principal Investigator: John Blakey, MD         
Korea, Republic of
Jeonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of, 54907
Contact: MiYoung Oh    + 82 10 4922 0343    pure53@naver.com   
Principal Investigator: Yonchul Lee, MD         
Hanyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of, 04763
Contact: Sumi So    1092610942    ssossum2144@gmail.com   
Principal Investigator: Sang Heon Kim, MD         
New Zealand
New Zealand Research Sleep Institute Recruiting
Auckland, New Zealand, 1010
Contact: Melissa Gane    +64 9-638 5255    melissa@nzrsi.health.nz   
Contact: Fay Sommerville    +64 9-638 5255    fay@nzrsi.health.nz   
Principal Investigator: Michelle Baker, MD         
New Zealand Clinical Research-Auckland Recruiting
Auckland, New Zealand, 1051
Contact: Taisha Stowers    +6 49 373 3479    Taisha.Stowers@nzcr.co.nz   
Principal Investigator: Mark O'Carroll, MD         
Poland
Prywatny Gabinet Internistyczno-Alergologiczny Recruiting
Białystok, Poland, 15-010
Contact: Grzegorz Siergiejko    48 601 896 534    siergiejko.grzegorz@gmail.com   
Principal Investigator: Zenon Siergiejko, MD         
Krakmed.NZOZ Recruiting
Kraków, Poland, 31-455
Contact: Aleksandra Hajol-Gora    48508299646    ola.hajolgora@gmail.com   
Principal Investigator: Elzbieta Hajol, MD         
Medicome SP.ZO.O Recruiting
Oświęcim, Poland, 32-600
Contact: Anna Olejniczak    48570907205    aolejniczak@medicome.pl   
Principal Investigator: Iwona Kobielsz-Gembala, MD         
Spain
Giromed Institute Barcelona Recruiting
Barcelona, Spain, 08017
Contact: Elisabet Arboix    +34972183397    elisabet.arboix@giromedinstitute.com   
Principal Investigator: Juan Roldan Sanchez, MD         
Thailand
Sriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Walaiporn Wongsrisakunkaew    6695-512-2590    walaiporn_noon@AROMUCRAGE.onmicrosoft.com   
Principal Investigator: Kittipong Maneechotesuwan, MD         
Sponsors and Collaborators
Arrowhead Pharmaceuticals
More Information
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05292950    
Other Study ID Numbers: AROMUC5AC-1001
2022-003467-21 ( EudraCT Number )
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes