Phase
Condition
Cystic Fibrosis
Asthma
Lung Disease
Treatment
ARO-RAGE
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Mater Hospital
South Brisbane, Queensland 4101
AustraliaSite Not Available
Institute for Respiratory Health-Perth
Nedlands, Western Australia 6009
AustraliaSite Not Available
Jeonbuk National University Hospital
Jeonju, 54907
Korea, Republic ofSite Not Available
Hanyang University Seoul Hospital
Seoul, 04763
Korea, Republic ofSite Not Available
New Zealand Clinical Research
Auckland, 1010
New ZealandSite Not Available
New Zealand Respiratory and Research Institute
Auckland, 1051
New ZealandSite Not Available
Pacific Clinical Research Network (PCRN)
Auckland, 622
New ZealandSite Not Available
Prywatny Gabinet Internistyczno-Alergologiczny
Białystok, 15-010
PolandSite Not Available
Krakmed.NZOZ
Kraków, 31-455
PolandSite Not Available
Medicome SP.ZO.O
Oświęcim, 32-600
PolandSite Not Available
Giromed Institute Barcelona
Barcelona, 08017
SpainActive - Recruiting
Pectus Respiratory Health
Barcelona, 08017
SpainSite Not Available
Sriraj Hospital
Bangkok Noi, Bangkok 10700
ThailandSite Not Available
Vajira Hospital
Bangkok, 10300
ThailandSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.