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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514809-67-00

Acronym

AROMUC5AC-1001

Enrollment

Registered

2024-07-24

Start date

2023-06-21

Completion date

2024-10-24

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma and Chronic obstructive pulmonary disease

Brief summary

The incidence and frequency of treatment-emergent adverse events (TEAEs) over time through end of study (EOS)

Detailed description

1. Change from baseline over time through EOS in forced expiratory volume (FEV1) as a safety assessment, 2. Change from baseline over time through EOS in forced vital capacity (FVC) as a safety assessment, 3. Plasma PK parameters of ARO-MUC5AC

Interventions

DRUG0.9% sodium chloride - inhalation solution

DRUGARO-MUC5AC Inhalation Solution

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The incidence and frequency of treatment-emergent adverse events (TEAEs) over time through end of study (EOS)	—

Secondary

Measure	Time frame
1. Change from baseline over time through EOS in forced expiratory volume (FEV1) as a safety assessment, 2. Change from baseline over time through EOS in forced vital capacity (FVC) as a safety assessment, 3. Plasma PK parameters of ARO-MUC5AC	—

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026