PEG Interferon Japanese Bridging Study
Research type
Research Study
Full title
A Two Arm, Open Label, Single Dose, Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of Peginterferon Beta 1a (BIIB017) in Japanese and Caucasian Adult Healthy Subjects
IRAS ID
139987
Contact name
Joseph Chiesa
Contact email
Sponsor organisation
Biogen Idec MA Inc
Eudract number
2013-002912-28
ISRCTN Number
N/A
Research summary
Peginterferon beta-1a (BIIB017) is a drug currently being developed as a potential treatment for multiple sclerosis (MS).
MS is a disease affecting nerves in the brain and spinal cord, causing problems with muscle movement, balance and vision. It is estimated that there are currently around 100,000 people with MS in the United Kingdom. Symptoms usually first develop between the ages of 20 and 40, with the average age of diagnosis being about 30.
There is currently no cure for MS, however there are treatments available that slow the progression of the disease. Interferon beta-1a are a group of drugs administered as an injection under the skin that have been shown to slow the progression of the disease by reducing inflammation of the nerves. However currently prescribed interferon beta-1a treatments such as Abonex or Rebif are relatively short acting therefore the patient has to be injected up to three times a week. BIIB017 acts in a similar way to interferon beta-1a treatments but has been shown to be longer acting than the currently available treatments and therefore patients require fewer injections.
The study drug (BIIB017) has been tested in previous clinical trials. As of 24 October 2012, BIIB017 has been given to 1664 people in clinical studies. These studies included healthy volunteers, patients with reduced kidney function, and patients with MS.
This study will be carried out in Japanese and Caucasian adult healthy subjects. The main purpose would be to assess the pharmacokinetic properties (blood drug levels and rate of removal from the body) in addition to safety and tolerability of BIIB017.
During the study, each subject will receive a single dose of BIIB017 administered subcutaneously (as an injection under the skin).
Subject participation is expected to last up to 2 months from the time of screening till the last post-study visit.REC name
North East - York Research Ethics Committee
REC reference
13/NE/0284
Date of REC Opinion
23 Oct 2013
REC opinion
Further Information Favourable Opinion