Study Evaluating Effects of ARO-MUC5AC in Asthma and COPD patients
Research type
Research Study
Full title
A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients with Muco-Obstructive Lung Disease
IRAS ID
1007091
Contact name
Ramesh Shukla
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals, Inc.
Eudract number
2022-003467-21
Clinicaltrials.gov Identifier
Research summary
This is a first-in-human, randomized, placebo-controlled study of ARO-MUC5AC in healthy volunteers and in patients with muco-obstructive lung disease, including asthma and COPD. This is a multi-site trial with large hospital institutions as well as small private clinics participating in Australia, New Zealand, Thailand, South Korea, Spain and Poland. The study is now expanding into the UK where In the UK, the study will enroll patients with asthma orand COPD at a single clinical research trial site. ARO-MUC5AC is a drug that is intended to decrease airway mucus production in patients with muco-obstructive lung disease . This clinical study is being performed to understand whether ARO-MUC5AC may be a safe and effective treatment for asthma and COPD. Subjects who enroll in the study will be randomly allocated to receive either ARO-MUC5AC (delivered to the lung by oral inhalation of an aerosol) or placebo (salt water). In the initial component of the study (performed outside the UK), groups of healthy volunteers will receive a single dose of ARO-MUC5AC, or placebo, at escalating dose levels. Following review of safety findings from those healthy volunteers, subjects (either healthy volunteers or patients with asthma or COPD) will receive multiple doses (3 total doses at 2-week intervals) of ARO-MUC5AC, or placebo, at escalating dose levels. Subjects will then be followed for up to a total of 85 days to evaluate the effects of the treatment. The primary objective of the study will be to assess the safety and tolerability of ARO-MUC5AC. Secondary and exploratory objectives will be to assess the effects of ARO-MUC5AC on lung function, the levels of ARO-MUC5AC absorbed into the blood, and the effects of ARO-MUC5AC on mucus production in the lung.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0299
Date of REC Opinion
23 May 2024
REC opinion
Further Information Favourable Opinion