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A Phase IIa Study of Z-207 in Patients with Seasonal Allegic Rhinitis - Investigation of the Efficacy and Safety of Z-207 after Single Injection

Phase 2
Conditions
Seasonal Allergic Rhinitis
Registration Number
JPRN-jRCT2080221241
Lead Sponsor
Zeria Pharmaceutical Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
48
Inclusion Criteria

Patient with history of moderate to sever seasonal allergic rhinitis for at least 2 years
Patient with positive reaction for Radio Allergen Sorbent Test using Japanease ceder pollen
Patient exhibit both a total nasal symptom score of at least 4, and a nasal obstruction score of at least 2 under exposure to allergen using pollen challenge chamber ( Total nasal symptom score is the sum of sneezing, nasal discharge, nasal obstruction which has been scored on a scale from 0 to 4 )

Exclusion Criteria

Patient with positive reaction for Radio Allergen Sorbent Test for house dust mite
Patient with positive reaction for Radio Allergen Sorbent Test for orchard grass pollen
Patient who never received medical drug therapy for allergic rhinitis

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total nasal symptom score under exposure to allergen using pollen challenge chamber, and nasal symptom score natural exposure to allergen during the pollen season
Secondary Outcome Measures
NameTimeMethod
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