NCT06488521

A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers

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: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 256 (estimated)
• 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 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 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. 256 patients (128 to the study drug group and 128 to the comparator drug group) are being randomized.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Complarate	Complarate solution, a subcutaneous injection at a single dose of 162 mg.
BIOLOGICAL	Actemra®	Actemra® solution, subcutaneous injection at a single dose of 162 mg.

Timeline

• Start date: 2024-06-20
• Primary completion: 2025-04-30
• Completion: 2025-09-30
• First posted: 2024-07-05
• Last updated: 2025-07-30

Locations

3 sites across 1 country: Russia