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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.

NCT07155499 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-04

No results posted yet for this study

Summary

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.

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

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-07
Primary Completion
2025-05-31
Completion
2025-12-20

Countries

  • Russia

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 NCT07155499 on ClinicalTrials.gov