NCT07326995

Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma

A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anhui Palo Alto Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 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 Inhalation Aerosol in patients with bronchial asthma.

Detailed description

This is a multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial. Subjects of 60 with bronchial asthma are planned to be included in this study. With a ratio of 1: 1: 1: 1 to be randomized allocated to receive PA9159 Inhaler of 60 μg, 120 μg, and 240 μg, or placebo, with 15 subjects in each group. The duration of this study is approximately 42 days, including screening, baseline, treatment observation, and follow-up.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	PA9159 Metered-Dose Inhaler, 60 μg per day for 28 days	PA9159 of 60 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
DRUG	PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days	PA9159 of 120 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
DRUG	PA9159 Metered-Dose Inhaler, 240 μg per day for 28 days	PA9159 of 240 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
DRUG	Placebo Metered-Dose Inhaler without PA9159, Twice daily for 28 days	Placebo is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: China