Status:
COMPLETED
Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2025
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT05276570
Start Date
June 29 2022
End Date
April 16 2025
Last Update
September 24 2025
Active Locations (8)
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1
Research Site 1
Nedlands, Washington, Australia, 6009
2
Research Site 1
Auckland, New Zealand, 1010
3
Research Site 2
Auckland, New Zealand, 1051
4
Research Site 3
Auckland, New Zealand, 622