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

Prior treatment

• Acute lower respiratory infection or asthma exacerbation within 30 days prior to first dose
• 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
• 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

Other illness

• Positive COVID-19 test during Screening window
• Human Immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
• Uncontrolled hypertension

Other

• Clinically significant health concerns (other than asthma in asthma patients)
• Unwilling to limit alcohol consumption to within moderate limits for the duration of the study

• 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