* 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
Exclusion Criteria:
* 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
Note: additional inclusion/exclusion criteria may apply per protocol
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
ARO-MUC5AC
ARO-MUC5AC Inhalation
Donnée non disponible
Inconnu
Placebo
(0.9% NaCl)
Donnée non disponible
Inconnu
ARO-MUC5AC
État du recrutement
unknown
ARO-MUC5AC Inhalation
Placebo
État du recrutement
unknown
(0.9% NaCl)
Données à jour depuis :
12 décembre 2024
Description de l'étude
Description de l'étude
Résumé de l'étude
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
13
centres
HANYANG UNIVERSITY SEOUL HOSPITAL
Seoul
SEOUL, KOREA, REPUBLIC OF
Recrutement local
État du recrutement:
FERMÉ
INSTITUTE FOR RESPIRATORY HEALTH - PERTH
Nedlands
AUSTRALIA
Recrutement local
État du recrutement:
FERMÉ
JEONBUK NATIONAL UNIVERSITY HOSPITAL
Jeonju-si
OTHER, KOREA, REPUBLIC OF
Recrutement local
État du recrutement:
FERMÉ
KRAKMED.NZOZ
Kraków
POLAND
Recrutement local
État du recrutement:
FERMÉ
MATER HOSPITAL BRISBANE
South brisbane
QUEENSLAND, AUSTRALIA
Recrutement local
État du recrutement:
FERMÉ
MEDICOME SP.ZO.O
Oświęcim
POLAND
Recrutement local
État du recrutement:
FERMÉ
NEW ZEALAND CLINICAL RESEARCH-AUCKLAND
Auckland
NEW ZEALAND
Recrutement local
État du recrutement:
FERMÉ
NEW ZEALAND RESEARCH SLEEP INSTITUTE
Auckland
NEW ZEALAND
Recrutement local
État du recrutement:
FERMÉ
PECTUS RESPIRATORY HEALTH SL
Barcelona
SPAIN
Recrutement local
État du recrutement:
FERMÉ
PRYWATNY GABINET INTERNISTYCZNO-ALERGOLOGICZNY
Białystok
PODLASKIE, POLAND
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
12 décembre 2024
Données à jour depuis :
14 déc.
Origine des données :
clinicaltrials.gov