Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, in parallel groups comparative study of pharmacokinetics,
      pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation)
      and Xolair® ("Novartis Pharma AG", Switzerland) after single subcutaneous administration in
      healthy volunteers at 150 mg
    

Detailed description: 
      There is an increasing incidence of bronchial asthma (BA) and other allergic diseases around
      the world. Bronchial asthma suffers from 4 to 10% of the world population, in Russian
      Federation, the incidence of BA across the adult population ranges from 2.2 to 5-7%, in the
      child population is about 10%.

      Severe BA is associated not only with frequent hospitalizations and increased mortality but
      also with high treatment costs.

      As to it, there is a hot button issue of developing new drugs for treating patients not to be
      achieved effectively with standard therapy. 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. These anti-IgE antibodies effects have been shown in various
      studies.

      One of these drugs is оmalizumab (Xolair®). The drug has been approved in various countries
      across the world, including the United States and the European Union for the severe allergic
      BA and chronic idiopathic urticaria treatment. In the Russian Federation, omalizumab was
      registered in May 2007.

      The drug GNR-044 (JSC "GENERIUM", Russian Federation) is biosimilar to the original drug
      Xolair®. This study is aimed to compare the safety and pharmacokinetics of the drug GNR-044
      (JSC "GENERIUM", Russian Federation) and the drug Xolair® in order to register of the drug
      GNR-044 (JSC "GENERIUM", Russian Federation), a lyophilizate for subcutaneous administration,
      in the Russian Federation.
    

Intervention name(s): Omalizumab (JSC "GENERIUM", the Russian Federation); Xolair® (Novartis Pharma AG, Switzerland)
Intervention type(s): Biological; Biological
Intervention description(s): 150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area; 150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area
Other intervention name(s): omalizumab; GNR-044; omalizumab
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional
Masking: None (Open Label)
Primary purpose: Other
Keywords: omalizumab; humanized monoclonal antibodies; total or free IgE; pharmacokinetics; pharmacodynamics; safety; bronchial asthma; health volunteers; equivalence; biosimilar; anti-allergic agents; anti-asthmatic agents; respiratory system agents; hypersensitivity; immune system diseases; urticaria