drugset / Trial / NCT01439971

Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia

NCT01439971 ↗

Phase 1 Completed 29 enrolled Catalyst Biosciences
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

EvaluationDrugModalityDoseRoute
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

Indications