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ACTIVE NOT RECRUITING
NCT06488521
PHASE1

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

Sponsor: AO GENERIUM

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2024-06-20

Completion Date

2025-09-30

Last Updated

2025-07-30

Healthy Volunteers

Yes

Interventions

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.

Locations (3)

State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"

Moscow, Moscow, Russia

Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov Ministry of Health of Russia

Moscow, Moscow, Russia

LLC "X Seven Clinical Research"

Saint Petersburg, Sankt-Peterburg, Russia