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Safety and Efficacy Study of PA9159 Nasal Spray for the Treatment of Seasonal Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of PA9159 Nasal Spray for the Treatment of Seasonal Allergic Rhinitis

Clinical Trial Summary

PA9159 is a highly potent novel corticosteroid. The purpose of this study is to evaluate the safety, efficacy and characteristics of population pharmacokinetics of multiple dosing of PA9159 Nasal Spray in patients with seasonal allergic rhinitis.

Clinical Trial Description

This is a multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial. Subjects of 200 with seasonal allergic rhinitis are planned to be included in this study. With a ratio of 1: 1: 1: 1 to be randomized allocated to receive PA9159 Nasal Spray of 10 μg, 20 μg, and 40 μg, or placebo, with 50 subjects in each group. The duration of this study is approximately 12 months, including screening, baseline, treatment observation, and follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05234580
Study type Interventional
Source Anhui Palo Alto Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date April 15, 2022
Completion date December 25, 2022
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