Phase 1Completed

Phase I, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers

Phase I, Double-Blind, Randomized, Three-Arm, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study in Healthy Volunteers to Evaluate Bioequivalence of LusiNEX and Tocilizumab (EU and US)

Sponsor: Mycenax Biotech Inc. (Industry)
Enrolment: 190 enrolled
Conditions: Pharmacokinetics
Interventions: Tocilizumab
Ages: adults
Registry: NCT03522012

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

Pharmacokinetics

History

Last registry update
26 Feb 2019
Study completion
20 Dec 2018
Primary completion
26 Sept 2018
Registered
11 May 2018
Started
17 Oct 2017