Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers
Status:
Completed
Trial end date:
2018-12-20
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, 3-arm, parallel-group single-dose study to compare the
PK, PD, safety, tolerability, and immunogenicity of LusiNEX (Mycenax tocilizumab) versus
RoActemra (EU tocilizumab) and Actemra (US tocilizumab) after a single IV infusion of 4 mg/kg
in healthy volunteers (hereafter referred to as subjects). The therapeutic dose of
tocilizumab starts with 4 mg/kg and ranges to 12 mg/kg, considering 4 mg/kg is the lowest
dose, the same has been selected for the study.