NCT05276570

Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease (asthma). In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with asthma will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

Conditions

• Asthma

Interventions

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

Timeline

• Start date: 2022-06-29
• Primary completion: 2025-04-16
• Completion: 2025-04-16
• First posted: 2022-03-11
• Last updated: 2026-04-09

Locations

8 sites across 5 countries: Australia, New Zealand, Poland, Spain, Thailand

Regulatory

• FDA-regulated drug study