Comparative Clinical Study of Pharmacokinetics, Tolerance and Safety of BCD-057 and Humira in Healthy Volunteers
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic
equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar
candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous
injection in healthy volunteers.