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.

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

October 7, 2024

Primary Completion Date

May 31, 2025

Study Completion Date

December 20, 2025

Conditions
Rhinitis, Allergic, Seasonal
Interventions
BIOLOGICAL

GNR-127, 20 mcg

GNR-127, 20 mcg in 0.5 ml administered 5 times every 4 weeks

BIOLOGICAL

GNR-127, 40 mcg

GNR-127, 40 mcg in 0.5 ml administered 5 times every 4 weeks

BIOLOGICAL

GNR-127, 80 mcg

GNR-127, 80 mcg in 0.5 ml administered 5 times every 4 weeks

BIOLOGICAL

GNR-127 placebo

GNR-127 placebo 0.5 ml administered 5 times every 4 weeks

Trial Locations (1)

115522

National Research Center - Institute of Immunology Federal Medical-Biological Agency, Moscow

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY

NCT07155499 - 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. | Biotech Hunter | Biotech Hunter