NCT06481189

A Safety, Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris® in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 G1/k (IgG1/k) 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 study/comparator drug and a follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1 to the study drug and comparator drug. 105 patients (53 to the study drug group and 52 to the comparator drug group) were randomized.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	GNR-086	The test drug GNR-086 was administered as a subcutaneous injection at a single dose of 150 mg.
BIOLOGICAL	Ilaris®	The reference drug Ilaris® was administered as a subcutaneous injection at a single dose of 150 mg.

Timeline

• Start date: 2022-09-06
• Primary completion: 2023-03-17
• Completion: 2023-05-26
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

2 sites across 1 country: Russia