Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481202
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-20
Brief Title:
A Safety and Pharmacokinetic Study of Complarate Tocilizumab Biosimilar and Actemra in Healthy Volunteers
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
Double-blind Randomized Study of the Safety Pharmacokinetics and Pharmacodynamics of the Drugs Complarate JSC GENERIUM Russia and Actemra F Hoffmann-La Roche Ltd Switzerland in Parallel Groups of Healthy Volunteers
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 randomized double-blind comparative parallel group study of the safety pharmacokinetics and pharmacodynamics of Complarate and Actemra in healthy volunteers Participants received a single intravenous dose of tocilizumab 8 mgkg The follow up period was 43 days
Detailed Description:
Complarate tocilizumab is being developed as a biosimilar to the drug Actemra a concentrate for the preparation of a solution for infusion
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 IL-6 receptor from the immunoglobulin G1 IgG1 subclass of immunoglobulins Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors sIL-6R and mIL-6R
This I phase study is aimed to compare the pharmacokinetics and safety of the drugs Complarate and Actemra after their single intravenous administration to healthy volunteers at a dose of 8 mgkg The study included healthy volunteers aged 18-45 years at the time of signing the informed consent form The study included a screening period single administration of studycomparator drug and a follow up period Allocation of patients to treatment groups was carried out by randomization in a ratio of 11 to the study drug and comparator drug 46 healthy volunteers 23 to the study drug group and 23 to the reference drug group were randomized
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 IL-6 receptor from the immunoglobulin G1 IgG1 subclass of immunoglobulins Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors sIL-6R and mIL-6R
This I phase study is aimed to compare the pharmacokinetics and safety of the drugs Complarate and Actemra after their single intravenous administration to healthy volunteers at a dose of 8 mgkg The study included healthy volunteers aged 18-45 years at the time of signing the informed consent form The study included a screening period single administration of studycomparator drug and a follow up period Allocation of patients to treatment groups was carried out by randomization in a ratio of 11 to the study drug and comparator drug 46 healthy volunteers 23 to the study drug group and 23 to the reference drug group were randomized
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