ARORAGE-1001 - Inhalation Solution in Healthy Subjects and Patients With Inflammatory Lung Disease

ARO-RAGE is being developed as a potential asthma and CF treatment and is intended to reduce inflammation in the airways by blocking and inhibiting an important lung receptor (component) involved in the inflammatory response, known as RAGE (Receptor for Advanced Glycation End-products). By reducing inflammation and improving airflow, ARO-RAGE may be an effective treatment for asthma and CF.

Category
Trial Status
Recruiting
Trial Phase
Phase 1 Drug Trial
Registry Listing
ERM Project ID
98070
Trial contact details
Contact Person
RIO Clinical Trials Unit
What you need to know

Who can take part?

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

What is involved for me?

• Questions about your health, medications and whether you are
experiencing any side effects.
• Physical examination, if required.
• BMI
• Sets of vital signs
• Sets of safety blood and urine samples
• Sets of ECG
• A blood sample will be collected to check if your body has any
antibodies to the study drug.
• Spirometry test
• DLCO test
• Chest x-ray
• Blood samples for sRAGE, asthma biomarkers, inflammatory markers,
blood cytokine and blood counts.
• FeNO test
• Complete an Asthma Questionnaire

Eligible participants will receive two (2) doses of the study drug or placebo on Day 1 and Day 29, which will be administered by inhalation using a nebulizer (inhaled through the mouth). 

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