Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arrowhead Pharmaceuticals
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Normal pulmonary function tests at Screening (NHVs only)
Confirmed diagnosis of asthma or COPD based on source verifiable medical record (asthma and COPD patients only)
No abnormal finding of clinical relevance at Screening (NHVs only)
Stable dose of asthma controller medications for at least 28 days prior to Screening (asthma patients only)
Documented treatment with an inhaled corticosteroid and at least 1 additional maintenance asthma controller medication for at least 3 months prior to Screening (asthma patients only)
Non-smoking (NHVs and asthma patients)
Current smoker or ex-smoker with smoking history of ≥ 10 pack-years (COPD patients only)
All COPD treatments have been stable for at least one month prior to Screening (COPD patients only)
Able to produce an induced sputum sample at Screening
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 90 days following the last dose of study drug
Willing to provide written informed consent and to comply with study requirements
You may not be if
Acute lower respiratory infection within 30 days prior to first dose and/or acute upper respiratory infection within 7 days prior to first dose
Positive COVID-19 test during Screening window
Any history of chronic pulmonary disease (NHVs only)
Any concomitant pulmonary disease in asthma or COPD patients that could interfere with the evaluation of the study drug or interpretation of patient safety or study results
Use of theophylline within 30 days prior to first dose
History of lung volume reduction surgery or pneumonectomy (COPD patients)
Need for chronic oxygen support at Screening
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
Clareo Health | Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
