A study to investigate a new drug in healthy and haemophilia subjects

• Research type

  Research Study

• Full title

  A multi-centre, open-labelled, multiple dosing trial investigating safety, pharmacokinetics and pharmacodynamics of NNC 0172-2021 administered subcutaneously to healthy male subjects and haemophilia subjects

• IRAS ID

  104078

• Contact name

  John Lambert

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2011-005757-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  NNC 0172-2021 is being investigated as a treatment of haemophilia. The main purpose of the study is to assess the safety of subcutaneous (s.c.) administration of multiple dosing of NNC 0172-2021 in healthy subjects and subjects with haemophilia. The study also aims to describe the pharmacokinetics (PK) and pharmacodynamics (PD) of NNC 0172-2021 after multiple s.c. doses in healthy subjects and subjects with haemophilia. Please note that PAREXEL are preparing the Ethics submission and arranging for the study to be approved in the UK. The study drug is currently tested in studies approved in the UK: First human dose: NN7415-3813; Rec: 10/H09O3/44Japanese single ascending dose: NN7415-3921; Rec: 12/EE/0056 For the present study, PAREXEL are only dosing the healthy volunteer subjects. The patients will be recruited outside the UK as a result specific patient documents will be not be submitted to the UK Ethics Committee. Healthy subjects will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. In total, twelve subjects will be dosed in the entire study. The trial product NNC 0172-2021 will be administered to the trial subjects in the clinic under the surveillance of medically trained trial staff. The study duration for each subject will be approximately 56 days, which includes the screening phase. The trial consists one screening visit, followed by 8 dosing visits, one follow-up visit and the end of trial visit. Blood samples will be collected and safety monitored throughout the study period.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  12/SC/0210

• Date of REC Opinion

  30 Apr 2012

• REC opinion

  Favourable Opinion