NCT05292950

Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease

A Phase 1/2a Study Evaluating the Effects of ARO-MUC5AC Inhalation Solution in Healthy Subjects and Patients With Muco-Obstructive Lung Disease

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	ARO-MUC5AC	single or multiple doses of ARO- MUC5AC by inhalation of nebulized solution
DRUG	Placebo	calculated volume to match active treatment by inhalation of nebulized solution

Timeline

• Start date: 2022-06-27
• Primary completion: 2024-11-12
• Completion: 2024-11-12
• First posted: 2022-03-23
• Last updated: 2025-11-05

Locations

13 sites across 7 countries: Australia, New Zealand, Poland, South Korea, Spain, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study