Bioequivalence study of two formulations of caplacizumab (ALX0681-C10)

• Research type

  Research Study

• Full title

  A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.

• IRAS ID

  154860

• Contact name

  Pui Leung

• Contact email

  pui.leung@quotientclinical.com

• Sponsor organisation

  Ablynx NV

• Eudract number

  2014-001294-13

• ISRCTN Number

  To be registered

• REC name

  Wales REC 2

• REC reference

  14/WA/0168

• Date of REC Opinion

  30 May 2014

• REC opinion

  Further Information Favourable Opinion