drugset / Trial / NCT01153997
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects. In addition pharmacokinetic parameters will be investigated.
Timeline
- Start
- 2010-06
- Primary completion
- 2010-08
- Completion
- 2010-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | catridecacog | Protein / enzyme biologic | 12 iu/kg | Intravenous |
| Subject | catridecacog | Protein / enzyme biologic | 35 iu/kg | Intravenous |