drugset / Trial / NCT00822185
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined
Timeline
- Start
- 2009-01
- Primary completion
- 2009-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vatreptacog alfa (activated) | Protein / enzyme biologic | 5 ug/kg | Intravenous |
| Subject | vatreptacog alfa (activated) | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | vatreptacog alfa (activated) | Protein / enzyme biologic | 20 ug/kg | Intravenous |
| Subject | vatreptacog alfa (activated) | Protein / enzyme biologic | 30 ug/kg | Intravenous |