drugset / Trial / NCT00951873
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).
Timeline
- Start
- 2009-07
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EPTACOG ALFA PEGOL (ACTIVATED) | Protein / enzyme biologic | 0.1 mg/kg | Subcutaneous |
| Subject | EPTACOG ALFA PEGOL (ACTIVATED) | Protein / enzyme biologic | 0.3 mg/kg | Subcutaneous |
| Subject | EPTACOG ALFA PEGOL (ACTIVATED) | Protein / enzyme biologic | 0.5 mg/kg | Subcutaneous |