Phase I Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of BIIB800 s.c
Research type
Research Study
Full title
A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. compared to Actemra® in Healthy Male Participants
IRAS ID
1009030
Contact name
Martin Hunn
Contact email
Sponsor organisation
Biogen International GmbH
Research summary
This is an early phase clinical trial of BIIB800, an investigational drug being developed by Biogen MA Inc. to be given subcutaneously (under the skin). It is hoped BIIB800 will help people suffering from problems with the immune system (the body’s defense system against infection) which cause inflammatory diseases such as rheumatoid arthritis (a painful inflammatory condition of the joints and other body tissues).
BIIB800 contains the drug tocilizumab and is designed to be very similar to medicines that have been available as subcutaneous injections since 2014 called Actemra and RoActemra. Tocilizumab specifically targets and blocks a protein in the body called the interleukin-6 receptor (IL-6R) which is elevated in inflammatory conditions. By reducing the levels of IL-6R and changing the way the immune system works, tocilizumab helps reduce the overactive inflammatory processes associated with these conditions.
This trial will compare BIIB800 with Actemra and will look at how the body handles the drugs, how the drugs affects certain chemicals within the body, how safe and well-tolerated the drugs are and the effect of the drugs on antibodies (proteins produced by your body’s immune system).
The study aims to enroll a total of 300 male subjects across 4 research sites in the United States and United Kingdom. 150 subjects will receive treatment with BIIB800, and 150 with Actemra. This is a ’double-blind’ trial, meaning that neither the study team nor the subjects will be aware of which drug they receive.
Subjects will be assessed for eligibility within 35 days prior to checking into the research unit on Day -1. On Day 1, subjects will be randomly allocated to receive either 162mg of BIIB800 or 162mg of Actemra as a single injection into one arm. Subjects will remain in the research unit until Day 8 and will attend for a further seven outpatient visits up to Day 57. Total trial duration is therefore expected to be approximately 13 weeks.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0900
Date of REC Opinion
30 Jan 2024
REC opinion
Further Information Favourable Opinion