NCT01439971

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

An Ascending Single Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics/Pharmacodynamics Of Pf-05280602, A Recombinant Factor Viia Variant (813d), In Adult Hemophilia A And B Subjects With Or Without Inhibitors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Catalyst Biosciences · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	PF-05280602	0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose
BIOLOGICAL	PF-05280602	4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose
BIOLOGICAL	PF-05280602	9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose
BIOLOGICAL	PF-05280602	18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose
BIOLOGICAL	PF-05280602	30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-09-23
• Last updated: 2017-05-12
• Results posted: 2017-04-06

Locations

23 sites across 8 countries: United States, Belgium, Hungary, Italy, New Zealand, South Africa, Turkey (Türkiye), United Kingdom