drugset / Trial / NCT01439971
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
Non-randomizedSequentialOpen-labelBasic science
Summary
This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.
Timeline
- Start
- 2011-12
- Primary completion
- 2015-10
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 0.5 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 4.5 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 9 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 18 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 30 ug/kg | Intravenous |