Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair® (NAP)

Generium

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: Omalizumab (JSC "GENERIUM", the Russian Federation); Biological: Xolair® (Novartis Pharma AG, Switzerland)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04601389

№88 eff.data 16 Feb 2017 (Registry Identifier)

OMA-HVL-I

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and women between the ages of 18 and 50 (inclusive) at the time of the Informed Consent Form.
2. The diagnosis is "healthy" according to haematology and biochemical blood tests, urinalysis, results of physical examination, measurements of vital signs, results of electrocardiography.
3. Bodyweight from 40 to 90 kg inclusive.
4. Body mass index 18.5-30 kg / m2 inclusive.
5. Initial concentration of total IgE: ≥30 IU / ml and ≤300 IU / ml.
6. Comply with the rules of contraception by the study participants.

Exclusion criteria

1. Monoclonal antibodies administration within 1 year before taking omalizumab.
2. Hypersensitivity to any of the used study drug, to their components, history of an undesirable drug reaction.
3. Concurrent diseases and conditions with potential impact on the patient's safety, pharmacokinetics or pharmacodynamics.
4. The drug's use that affects pharmacokinetics or pharmacodynamics (injectable glucocorticosteroid drugs, allergen-specific immunotherapy, immunosuppressive drugs, vaccination within 30 days before signing informed consent and/or the need for vaccination during the study period).
5. Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
6. Patients with severe medical conditions that in the view of the investigator prohibits participation in the study.
7. Concurrent therapy with investigational agents.
8. A history of autoimmune disease.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

GNR-044 (JSC "GENERIUM", the Russian Federation)

Experimental group

Description:

150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area

Treatment:

Biological: Omalizumab (JSC "GENERIUM", the Russian Federation)

Xolair® (Novartis Pharma AG, Switzerland)

Active Comparator group

Description:

150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area

Treatment:

Biological: Xolair® (Novartis Pharma AG, Switzerland)