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Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease

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ClinicalTrials.gov Identifier: NCT05276570
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : March 8, 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 of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease (asthma). In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with asthma will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

Condition or disease Intervention/treatment Phase
Asthma Drug: ARO-RAGE Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 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-RAGE Inhalation Solution in Healthy Subjects and Patients With Inflammatory Lung Disease
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: ARO-RAGE
ARO-RAGE Inhalation
 Drug: ARO-RAGE
single or multiple doses of ARO-RAGE 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: From first dose of study drug through the end of study (EOS; up to 113 days) ]

Secondary Outcome Measures :
  1. Change from Baseline Over Time in Forced Expiratory Volume (FEV1) [ Time Frame: Baseline through EOS (up to 113 days) or until serum soluble receptor for advance glycation end products (sRAGE) is ≥ 70% of baseline value ]
  2. Change from Baseline Over Time in Forced Vital Capacity (FVC) [ Time Frame: Baseline through EOS (up to 113 days) or until serum sRAGE is ≥ 70% of baseline value ]
  3. Change from Baseline Over Time in Diffusing Capacity for Carbon Monoxide (DLCO) [ Time Frame: Baseline through EOS (up to 113 days) or until serum sRAGE is ≥ 70% of baseline value ]
  4. PK of ARO-RAGE: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  5. PK of ARO-RAGE: Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  6. PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to 24 Hours (AUC0-24) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  7. PK of ARO-RAGE: 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 post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  8. PK of ARO-RAGE: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity (AUCinf) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  9. PK of ARO-RAGE: Terminal Elimination Half-Life (t1/2) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  10. PK of ARO-RAGE: Apparent Systemic Clearance (CL/F) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  11. PK of ARO-RAGE: Apparent Terminal-Phase Volume of Distribution (VZ/F) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]
  12. PK of ARO-RAGE: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount Excreted; Ae) [ Time Frame: Through 24 hours post-dose ]
  13. PK of ARO-RAGE: Percentage of Administrated Drug Recovered in Urine Over 0 to 24 hours [ Time Frame: Through 24 hours post-dose ]
  14. PK of ARO-RAGE: Renal Clearance (CLr) [ Time Frame: single dose phase: up to 48 hours post-dose; multiple dose phase: up to 6 hours post-dose on Days 1 and 29 for NHVs, and up to 24 hours post-dose for participants with asthma ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 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 based on source verifiable medical record (asthma patients only)
  • No abnormal finding of clinical relevance at Screening (other than asthma for asthma patients)
  • Stable dose of asthma controller medications prior to Screening (asthma patients only)
  • If on allergen-specific immunotherapy, participants must be on a stable maintenance dose
  • Non-smoking
  • 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 12 weeks 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 or asthma exacerbation within 30 days prior to first dose
  • Positive COVID-19 test during Screening window
  • Use of immunosuppressive medication within 90 days prior to first dose
  • Receipt of any intranasal vaccine within 30 days prior to first dose
  • Use of systemic corticosteroid therapy within 90 days prior to first dose
  • 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): NCT05276570


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

Locations
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Australia, Western Australia
Institute for Respiratory Health-Perth Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Meaghan Shorten    +61 51 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   
Contact: Kim         
Principal Investigator: Sang Heon Kim, MD         
New Zealand
New Zealand Clinical Research Recruiting
Auckland, New Zealand, 1010
Contact: Taisha Stowers    +64 937 33479    taisha.stowers@nzcr.co.nz   
Principal Investigator: Mark O'Carroll         
New Zealand Respiratory and Research Institute Recruiting
Auckland, New Zealand, 1051
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         
Poland
Prywatny Gabinet Internistyczno-Alergologiczny Recruiting
Białystok, Poland, 15-010
Contact: Grzegorz Siergiejko    48 60189 6534    siergiejko.grzegorz@gmail.com   
Principal Investigator: Zenon Siergiejko, MD         
Krakmed.NZOZ Recruiting
Kraków, Poland, 31-455
Contact: Aleksandra Hajol-Gora    48 50829 9646    ola.hajolgora@gmail.com   
Principal Investigator: Elzbieta Hajol, MD         
Medicome SP.ZO.O Recruiting
Oświęcim, Poland, 32-600
Contact: Anna Olejniczak       aolejniczak@medicome.pl   
Contact    48 57090 7205      
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 Noi, 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: NCT05276570    
Other Study ID Numbers: ARORAGE-1001
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: March 8, 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
Respiratory Tract Diseases