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

NCT05234580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis

Interventions

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.

Sponsors & Collaborators

  • Anhui Palo Alto Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Luo Zhang, phD · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2022-10-10
Completion
2022-12-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234580 on ClinicalTrials.gov