Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:17 AM
Study NCT ID:
NCT07326995
Status:
RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
Sponsor:
Anhui Palo Alto Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: