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

NCT ID: NCT04601389

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2017-09-06

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Omalizumab (JSC "GENERIUM", the Russian Federation)

Intervention Type BIOLOGICAL

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

Xolair® (Novartis Pharma AG, Switzerland)

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

Group Type ACTIVE_COMPARATOR

Xolair® (Novartis Pharma AG, Switzerland)

Intervention Type BIOLOGICAL

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

Interventions

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Omalizumab (JSC "GENERIUM", the Russian Federation)

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

Intervention Type BIOLOGICAL

Xolair® (Novartis Pharma AG, Switzerland)

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

Intervention Type BIOLOGICAL

Other Intervention Names

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omalizumab GNR-044 omalizumab

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AO GENERIUM

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oksana A Markova, MD

Role: STUDY_CHAIR

Head of the scientific department

Locations

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State budgetary institution of health care of the city of Moscow "City outpatients clinic No. 2 of the Department of Health of the city of Moscow"

Moscow, RF, Russia

Site Status

Federal State Budgetary Institution "State Scientific Center Institute of Immunology" by Federal Medical and Biological Agency of the Russian Federation

Moscow, , Russia

Site Status

Countries

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Russia

Related Links

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https://clinline.ru/reestr-klinicheskih-issledovanij/88-16.02.2017.html

Clinical Trials Register

Other Identifiers

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№88 eff.data 16 Feb 2017

Identifier Type: REGISTRY

Identifier Source: secondary_id

OMA-HVL-I

Identifier Type: -

Identifier Source: org_study_id