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ARO-MUC5AC
ARO-MUC5AC
Muco-obstructive
lung
phase 1
ARO-MUC5AC is designed to reduce production of mucin 5AC (MUC5AC) as a potential treatment for various muco-obstructive and inflammatory pulmonary diseases.
Clinical Trials
active
ID: NCT05292950
A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
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.
A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
Muco-obstructive
active
ID: NCT05292950
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.
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 12 weeks following the last dose of study drug
Willing to provide written informed consent and to comply with study requirements
Trial Details
Locations:
Australia, New Zealand, Poland, Thailand
Eligibility criteria:
18 Years to 70 Years (Adult, Older Adult), All Sexes, Accepts Healthy Volunteers
Active Clinical Trials
A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
Clinical Trials
active
ID: NCT05292950
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.
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 12 weeks following the last dose of study drug
Willing to provide written informed consent and to comply with study requirements
Trial Details
Locations:
Australia, New Zealand, Poland, Thailand
Eligibility criteria:
18 Years to 70 Years (Adult, Older Adult), All Sexes, Accepts Healthy Volunteers
active
A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease
Clinical Trials
ID: NCT05292950
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.
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