NCT06481202View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

April 11, 2022

Primary Completion Date

June 14, 2022

Study Completion Date

August 19, 2022

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

Complarate®

The test drug Complarate® was administered as an intravenous infusion at a single dose of 8 mg/kg.

BIOLOGICAL

Actemra®

The reference drug Actemra® was administered as an intravenous infusion at a single dose of 8 mg/kg.

Trial Locations (2)

119435

Department of Clinical Research, Center for Clinical Drug Research, Moscow

119991

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

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY