Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04601389
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2020-10-12
Brief Title:
Study of Pharmacokinetics Pharmacodynamics and Safety Assessment of GNR-044 JSC GENERIUM Russia and Xolair
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
An Open-label Randomized in Parallel Groups Comparative Study of Pharmacokinetics Pharmacodynamics Immunogenicity and Safety of Omalizumab JSC GENERIUM Russia and Xolair Novartis Pharma AG Switzerland After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAP
Brief 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 22 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 Š¾malizumab 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
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 Š¾malizumab 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 88 effdata 16 Feb 2017 | REGISTRY | Ministry of Health of Russia approval number | None |