A PK study of NNC172-2021 in healthy Japanese subjects

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, single centre, single dose trial, assessing the pharmacokinetics of NNC172-2021, administered subcutaneously at two different dose levels, in healthy Japanese subjects

• IRAS ID

  97536

• Contact name

  Muna Albayaty

• Sponsor organisation

  Novo Nordisk

• Eudract number

  2011-004575-36

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  NNC172-2021 is being investigated as a treatment for haemophilia. The main purpose of the study is to see how the study drug is taken up and distributed through the body. The study will also investigate how safe the study drug is and how well it is tolerated after dosing. The effects of the study drug on the body will also be tested. This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. Approximately 8 healthy participants of Japanese descent will be included in the study. Additional subjects may be enrolled if replacements are required. The study duration for each subject will be 33 days and the trial consists of a Screening Visit, a Dosing Visit and 10 follow up Visits. Blood samples will be collected and safety monitored throughout the investigational period.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  12/EE/0056

• Date of REC Opinion

  5 Mar 2012

• REC opinion

  Further Information Favourable Opinion