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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509654-60-00

Acronym

ARORAGE-1001

Enrollment

Registered

2024-07-05

Start date

2023-06-21

Completion date

2025-04-16

Last updated

2024-12-12

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

Conditions

Inflammatory Lung 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. Change from baseline over time through EOS in diffusing capacity for carbon monoxide (DLCO) as a safety assessment, 4. Plasma PK parameters of ARO-RAGE after each dose of study drug

Interventions

DRUG0.9% Sodium chloride - 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. Change from baseline over time through EOS in diffusing capacity for carbon monoxide (DLCO) as a safety assessment, 4. Plasma PK parameters of ARO-RAGE after each dose of study drug	—

Countries

Poland, Spain

Outcome results

None listed

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