A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis.

This is first-in-human phase 1/2 clinical trial to evaluate the safety, systemic and local reactogenicity of GNR-127 at the first stage in sequential cohorts of patients with allergic rhinitis with sensitization to the birch pollen, and then to determine and evaluate an effective and safe dose of the GNR-127 after five monthly administrations compared to placebo at the second stage.

NCT Number	NCT07155499
Lead Sponsor	AO GENERIUM
Conditions	Rhinitis, Allergic, Seasonal
Enrollment	150 participants
Start Date	2024-10-07
Primary Completion	2025-05-31 (estimated)
Study Completion	2025-12-20 (estimated)
Updated on ClinicalTrials.gov	2025-09-04