First in Human Study of ARC19499 in haemophilia patients

• Research type

  Research Study

• Full title

  A Phase 1, Single-Centre, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of ARC19499 Administered as Single and Multiple Ascending Doses to Haemophilia Patients.

• IRAS ID

  56410

• Contact name

  David Bevan

• Sponsor organisation

  Archemix Corp.

• Eudract number

  2010-020373-17

• Research summary

  The drug being tested in this trial is ARC19499. It is hoped that ARC19499 will be effective in reducing the bleeding episodes that occur in patients with haemophilia. In this study we are investigating the effects of ARC19499 in patients with haemophilia. This includes effects in blood clotting, tolerability, safety and how ARC19499 is broken down and eliminated by the body in patients with haemophilia. We will use various single and repeated ascending doses of ARC19499 during the study. The study will involve a maximum of 26 male haemophilia patients and will be last between 29 and 38 days in duration. The study will take place at Quintiles Drug research Unit at Guy's Hospital. The information gained in this study will help the sponsor to determine whether ARC19499 is suitable for further studies in haemophilia patients.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/54

• Date of REC Opinion

  19 Jul 2010

• REC opinion

  Further Information Favourable Opinion