drugset / Trial / NCT06481202

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

NCT06481202

Phase 1 Completed 43 enrolled AO GENERIUM
RandomizedParallel-groupDouble-blindOther

Summary

This is a randomized double-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of Complarate and Actemra® in healthy volunteers. Participants received a single intravenous dose of tocilizumab 8 mg/kg. The follow up period was 43 days

Timeline

Start
2022-04-11
Primary completion
2022-06-14
Completion
2022-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Complarate® Unknown 8 mg/kg Intravenous
Comparator Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications

No indication recorded.