NN7415-3813: Phase I Study of Anti-TFPI

• Research type

  Research Study

• Full title

  A multi-centre, randomised, double-blind, placebo-controlled, single dose, dose escalation trial investigating safety, pharmacokinetics and pharmacodynamics of NNC0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and haemophilia subjects.

• IRAS ID

  59296

• Contact name

  John R Lambert

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2010-020465-24

• ISRCTN Number

  N/A

• Research summary

  The trial is a multi-centre placebo-controlled, double-blind, single dose, dose escalation safety trial assessing NNC172-0000-2021 administered as single intravenous (into a vein) and subcutaneous (under the skin) doses to healthy subjects and haemophilia subjects. The trial is the first human dose trial with NNC-0172-0000-2021. Four trial participants will be included in each group, of which three trial participants will receive active treatment and one subject will receive placebo (dummy medication). After each group a Trial Safety Group will meet and discuss the results before the next step dose is given. This trial is designed to provide information regarding the safety profile and the pharmacokinetics (PK - measuring what happens to the drug in the body) and pharmacodynamics (PD - measuring the action of the drug in the body) of NNC-0172-0000-2021 after an intravenous (i.v.) or subcutaneous (s.c.) administration to healthy volunteers and patients with haemophilia A or B.NNC-0172-0000-2021 is produced by Novo Nordisk A/S in a laboratory using genetic recombinant methods and is produced without use of any animal products (free of animal based serum). Congenital haemophilia is an inherited bleeding disorder characterised by increased bleeding tendency due to either a partial or complete deficiency of the essential blood clotting factor VIII (haemophilia A) or IX (haemophilia B). Approximately 1 in 5,000 males have haemophilia A and 1 in 25,000 has haemophilia B.A total of approximately 56 participants will be randomised in this trial. The total duration of the trial will be approximately 8 -12 weeks for the participant.The trial will be conducted in healthy volunteers in the UK only and in haemophilia patients in the UK and other EU countries.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/44

• Date of REC Opinion

  20 Aug 2010

• REC opinion

  Favourable Opinion