NCT03522012

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Mycenax Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab is a recombinant human monoclonal antibody of the immunoglobulin G1 subclass, directed against the IL-6 ligand specific receptor. By preventing the binding of IL-6 to its receptor, tocilizumab inhibits the biological activity of IL-6. Tocilizumab was approved by the US Food and Drug Administration (4 mg/kg with an increase to 8 mg/kg based upon clinical response) for the treatment of adult patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to one or more tissue necrotizing factor (TNF) antagonist therapies. Tocilizumab is currently approved in 95 countries for the treatment of adult onset moderate to severe rheumatoid arthritis.

Timeline

• Start date: 2017-10-17
• Primary completion: 2018-09-26
• Completion: 2018-12-20
• First posted: 2018-05-11
• Last updated: 2019-02-26

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study