drugset / Trial / NCT05276570

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

NCT05276570 ↗

Phase 1/2 Completed 127 enrolled Arrowhead Pharmaceuticals
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2022-06-29
Primary completion
2025-04-16
Completion
2025-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject ARO-RAGE Unknown — Inhaled

Indications