NCT06481215

A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 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. 122 patients (60 to the study drug group and 62 to the comparator drug group) were randomized.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	GNR-068	The investigational product GNR-068 was administered as a subcutaneous injection at a single dose of 45 mg.
BIOLOGICAL	Stelara®	The reference product Stelara® was administered as a subcutaneous injection at a single dose of 45 mg.

Timeline

• Start date: 2022-03-11
• Primary completion: 2022-09-04
• Completion: 2022-12-20
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

2 sites across 1 country: Russia