NCT05234580

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Anhui Palo Alto Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	PA9159 nasal spray solution, 10 μg once daily for 14 days	PA9159 of 10 μg is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.
DRUG	PA9159 nasal spray solution, 20 μg once daily for 14 days	PA9159 of 20 μg is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.
DRUG	PA9159 nasal spray solution, 40 μg once daily for 14 days	PA9159 of 40 μg is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.
DRUG	Placebo nasal spray solution without PA9159, once daily for 14 days	Placebo nasal spray solution is delivered intranasally through a metered-dose mechanical spray pump, once daily in the morning for 14 days.

Timeline

• Start date: 2022-04-15
• Primary completion: 2022-10-10
• Completion: 2022-12-25
• First posted: 2022-02-10
• Last updated: 2023-02-01

Locations

17 sites across 1 country: China