DAC HYP: Japanese Bridging Study

• Research type

  Research Study

• Full title

  A Single-Dose, Single-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of DAC HYP in Japanese and Caucasian Adult Healthy Volunteers

• IRAS ID

  135828

• Contact name

  Jim Bush

• Contact email

  Jim.Bush@covance.com

• Sponsor organisation

  Biogen Idec Research Ltd

• Eudract number

  2013-002310-12

• ISRCTN Number

  N/A

• Research summary

  Daclizumab is a large molecule compound which has previously been marketed to prevent tissue rejection in organ transplant patients. The drug was withdrawn from the market due to commercial reasons; there were however no safety concerns with it. Daclizumab is now being developed by the Biogen as a potential treatment for multiple sclerosis (MS).
  In MS the body mounts an immune response to cells in the brain which is regulated by a type of cell called CD56bright NK cells. Daclizumab works by blocking the action of a chemical called interleukin-2 (IL2) which is produced by the body to create an immune response. In addition to reducing the immune response Daclizumab increases the number of CD56bright NK cells, it is therefore hoped it will be effective as a treatment for MS.
  This is a study to determine how DAC HYP (Daclizumab produced in a High Yield Process) is absorbed and broken down by the body following single subcutaneous doses in healthy Japanese and Caucasian volunteers. This study is being performed to aid regulatory approval in Japan and the results will also help to determine the dose level required to treat Japanese patients in the future.
  Each subject will receive a single dose of DAC HYP administered subcutaneously (as an injection under the skin) at dose levels of 75 mg or 150 mg. The dose level received by each Japanese subject will be chosen at random. Each Caucasian volunteer will be matched to an individual Japanese subject with a similar age and weight and will receive the dose at the same dose level as that Japanese subject.
  The levels of DAC HYP getting into the blood and the times taken for the drug to be removed from the blood will be measured and compared for each of the groups

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0213

• Date of REC Opinion

  29 Aug 2013

• REC opinion

  Further Information Favourable Opinion