Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494345
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-06-28
Brief Title:
A Study of Genolair in Two Dosage Forms Solution and Lyophilisate and Xolair in Healthy Volunteers
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
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
Status Verified Date:
2024-06
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:
None
Brief 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 IUml 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
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 IUml 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
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