Status:
TERMINATED
Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Asthma
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05292950
Start Date
June 27 2022
End Date
November 12 2024
Last Update
November 5 2025
Active Locations (13)
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1
Research Site 2
South Brisbane, Queensland, Australia, 4101
2
Research Site 1
Nedlands, Australia, 6009
3
Research Site 1
Auckland, New Zealand, 1010
4
Research Site 2
Auckland, New Zealand, 1051