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AROMUC5AC-1001

Study of aro-muc5ac in healthy subjects and patients with muco-obstructive lung disease
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05292950
Recrutement fermé
Dernière modification : 2024/12/12
Type de recherche

Interventionnel

Médicament expérimental

PHASE1


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* 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

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
    Placebo
    État du recrutement
    unknown
    Données à jour depuis : 12 décembre 2024

    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

    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

    Dernière modification : 12 décembre 2024
    Données à jour depuis : 14 déc.
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05292950