Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481215
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-20
Brief Title:
A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara in Healthy Volunteers
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
An Randomized Comparative Parallel-group Trial of the Safety Pharmacokinetics and Immunogenicity of the Drug GNR-068 and the Drug Stelara After Their Single Subcutaneous Administration to Healthy Volunteers at a Dose of 45 mg
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 open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara in healthy volunteers Participants received a single subcutaneous dose of ustekinumab 45 mg The follow up period was 84 days
Detailed Description:
GNR-068 ustekinumab is being developed as a biosimilar to the drug Stelara a solution for subcutaneous administration manufacturer Silag AG Switzerland holder of authority Johnson Johnson
Ustekinumab is a recombinant human monoclonal antibody against the p40 subunit The p40 subunit is common to interleukine-23 IL-23 and IL-12 IL-23 is a dimer consisting of p40 and p19 IL-12 is a dimer consisting of p40 and p35 With its target site p40 ustekinumab blocks two different mechanisms of T cell activation namely Th1 and Th17 selection
This study is intended for a comparative study of the safety and pharmacokinetics of the drug GNR-068 and the drug Stelara for the purpose of registration of the drug - GNR-068 solution for subcutaneous administration in the Russian Federation 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 122 patients 60 to the study drug group and 62 to the comparator drug group were randomized
Ustekinumab is a recombinant human monoclonal antibody against the p40 subunit The p40 subunit is common to interleukine-23 IL-23 and IL-12 IL-23 is a dimer consisting of p40 and p19 IL-12 is a dimer consisting of p40 and p35 With its target site p40 ustekinumab blocks two different mechanisms of T cell activation namely Th1 and Th17 selection
This study is intended for a comparative study of the safety and pharmacokinetics of the drug GNR-068 and the drug Stelara for the purpose of registration of the drug - GNR-068 solution for subcutaneous administration in the Russian Federation 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 122 patients 60 to the study drug group and 62 to the comparator 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