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

Sponsor
Mycenax Biotech Inc.
Study ID
NCT03522012
Phase
PHASE1
Status
Completed

Conditions

  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Tocilizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 17, 2017
Status verified
Nov 2018
Primary completion
Sep 26, 2018
Completion
Dec 20, 2018

Study Design

Enrollment
190 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LusiNex
    4 mg/kg, single-dose IV infusion (Mycenax tocilizumab)
  • Active Comparator: RoActemra
    4 mg/kg, single-dose IV infusion (RoActemra; tocilizumab marketed in EU )
  • Active Comparator: Actemra
    4 mg/kg, single-dose IV infusion (Actemra; tocilizumab marketed in US)

Primary Outcome Measure

Pharmacokinetics [ Time Frame: 2 months ]

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