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

Last updated: March 23, 2025
Sponsor: Arrowhead Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Cystic Fibrosis

Asthma

Lung Disease

Treatment

ARO-RAGE

Placebo

Clinical Study ID

NCT05276570
ARORAGE-1001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Normal pulmonary function tests at Screening (NHVs only)

  • Confirmed diagnosis of asthma based on source verifiable medical record (asthmapatients only)

  • No abnormal finding of clinical relevance at Screening (other than asthma for asthmapatients)

  • Stable dose of asthma controller medications prior to Screening (asthma patientsonly)

  • If on allergen-specific immunotherapy, participants must be on a stable maintenancedose

  • Non-smoking

  • Women of childbearing potential must have a negative pregnancy test, cannot bebreastfeeding, and must be willing to use contraception. Males must not donate spermduring 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

Exclusion Criteria:

  • Acute lower respiratory infection or asthma exacerbation within 30 days prior tofirst 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 ofthe 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

Study Design

Total Participants: 275
Treatment Group(s): 2
Primary Treatment: ARO-RAGE
Phase: 1/2
Study Start date:
June 29, 2022
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Mater Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Institute for Respiratory Health-Perth

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Jeonbuk National University Hospital

    Jeonju, 54907
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • New Zealand Clinical Research

    Auckland, 1010
    New Zealand

    Site Not Available

  • New Zealand Respiratory and Research Institute

    Auckland, 1051
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network (PCRN)

    Auckland, 622
    New Zealand

    Site Not Available

  • Prywatny Gabinet Internistyczno-Alergologiczny

    Białystok, 15-010
    Poland

    Site Not Available

  • Krakmed.NZOZ

    Kraków, 31-455
    Poland

    Site Not Available

  • Medicome SP.ZO.O

    Oświęcim, 32-600
    Poland

    Site Not Available

  • Giromed Institute Barcelona

    Barcelona, 08017
    Spain

    Active - Recruiting

  • Pectus Respiratory Health

    Barcelona, 08017
    Spain

    Site Not Available

  • Sriraj Hospital

    Bangkok Noi, Bangkok 10700
    Thailand

    Site Not Available

  • Vajira Hospital

    Bangkok, 10300
    Thailand

    Site Not Available

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