Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481189
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-20
Brief Title:
A Safety Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris in Healthy Volunteers
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
A Single-blind Randomized Parallel-group Comparative Study of the Pharmacokinetics Pharmacodynamics Safety and Immunogenicity of GNR-086 and Ilaris After a Single Subcutaneous Administration to Healthy Volunteers at a Dose of 150 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 single-blind comparative parallel group study of the safety pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris in healthy volunteers Participants received a single subcutaneous dose of canakinumab 150 mg The follow up period was 120 days
Detailed Description:
GNR-086 canakinumab is being developed as a biosimilar to the drug Ilaris a lyophilisate for the preparation of solution for subcutaneous administration
Canakinumab is a recombinant human monoclonal antibody against human interleukine-1β that belongs to the immunoglobulin G1k IgG1k isotype subclass
This study is intended for a comparative study of the safety pharmacokinetics and pharmacodynamics of the drug GNR-086 and the reference drug Ilaris for the purpose of registration of the drug - GNR-086 JSC GENERIUM Russia 150 mg lyophilisate for the preparation of 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 105 patients 53 to the study drug group and 52 to the comparator drug group were randomized
Canakinumab is a recombinant human monoclonal antibody against human interleukine-1β that belongs to the immunoglobulin G1k IgG1k isotype subclass
This study is intended for a comparative study of the safety pharmacokinetics and pharmacodynamics of the drug GNR-086 and the reference drug Ilaris for the purpose of registration of the drug - GNR-086 JSC GENERIUM Russia 150 mg lyophilisate for the preparation of 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 105 patients 53 to the study drug group and 52 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