Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488521
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
A Safety and Pharmacokinetics Study of Complarate Tocilizumab Biosimilar Solution and Actemra in Healthy Volunteers
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
A Single-blind Randomized Comparative Study of the Safety and Pharmacokinetics of Complarate and Actemra in the Form of a Solution for Subcutaneous Administration in Parallel Groups of Healthy Volunteers
Status:
RECRUITING
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 single-blind comparative parallel group study of the safety pharmacokinetics of the solution form of Complarate and Actemra in healthy volunteers Participants received a single subcutaneous dose of tocilizumab 162 mg The follow up period was 43 days
Detailed Description:
Complarate tocilizumab solution is being developed as a biosimilar to the drug Actemra a solution for subcutaneous injection
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 IL-6 receptor from the immunoglobulin G1 IgG1 subclass 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 subcutaneous administration to healthy volunteers at a dose of 162 mg 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 256 patients 128 to the study drug group and 128 to the comparator drug group are being randomized
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 IL-6 receptor from the immunoglobulin G1 IgG1 subclass 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 subcutaneous administration to healthy volunteers at a dose of 162 mg 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 256 patients 128 to the study drug group and 128 to the comparator drug group are being 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