NCT06494345

A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers

An Open-label Randomized Comparative Study in Parallel Groups of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Genolair as Solution and Lyophilisate Forms and Xolair® in a Solution Form

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in healthy volunteers

Detailed description

The drug Genolair (JSC "GENERIUM", Russia) is a humanized recombinant monoclonal antibody selectively binding to immunoglobulin E (IgE) and it can reduce the amount of free IgE, which is the trigger factor for a cascade of allergic reactions. Considering the leading pathogenesis role of IgE-mediated allergy, the use of drugs to block IgE makes it possible to control the disease at the earliest allergic reaction phase of the development. It was shown that the IgE elimination from the mast cells and basophils surface reduced the severity of acute allergic reactions, reduced the allergen-induced late phase of the immune response and infiltration with inflammatory cells. The drug Genolair is a biosimilar to the original drug Xolair® and it is registered in Russian Federation for therapy bronchial asthma and chronic idiopathic urticaria in the form of lyophilisate for the preparation of solution for subcutaneous administration. This study is aimed to compare the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the drug Genolair solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration and the drug Xolair® solution for subcutaneous administration to register of the drug Genolair (solution for subcutaneous administration) in the Russian Federation. In this open-label randomized parallel-group study adult volunteers (n = 180) aged 18 to 55 years with serum IgE level 30-300 IU/ml and body weight 50-90 kg receive a single subcutaneous dose (150 mg) of solution of the drug Genolair or lyophilisate for the preparation of solution of the drug Genolair or solution of the drug Xolair®. Serum concentrations of total omalizumab, free IgE and safety and immunogenicity will be determined up to 85 days post dose.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
BIOLOGICAL	Genolair, solution for subcutaneous administration, 150 mg	Genolair (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration
BIOLOGICAL	Genolair, lyophilisate for the preparation of solution for subcutaneous administration	Genolair (omalizumab), lyophilisate for the preparation of solution for subcutaneous administration, 150 mg for single subcutaneous administration
BIOLOGICAL	Xolair®, solution for subcutaneous administration, 150 mg	Xolair® (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-06-09
• Completion: 2024-06-09
• First posted: 2024-07-10
• Last updated: 2024-07-10

Locations

1 site across 1 country: Russia