A Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of PF-05280602, A Recombinant Factor VIIa Variant (813d), In Adult Subjects With Hemophilia A Or B

Status:	Completed
Conditions:	Anemia, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	18 - 64
Updated:	4/21/2016
Start Date:	December 2011
End Date:	February 2015

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

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.

Inclusion Criteria:

- Male subjects 18 to <65 years old with severe hemophilia A or B with or without
inhibitors to FVIII or FIX.

- Subjects is willing and able to comply with the mandatory washout periods prior to
screening and prior to dosing and through 48 hours post dosing. At screening this
includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this
includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72
hours through 48 hours post dosing.

- Subjects must agree and commit to using a a highly effective method of birth control
from the time of screening through four weeks after study drug administration.

Exclusion Criteria:

- Presence of a bleeding disorder in addition to hemophilia A or B.

- Regular, concomitant therapy with immunomodulating drugs (eg, intravenous
immunoglobulin, and routine systemic corticosteroids).

- History of coronary artery disease, thrombolic disease or diagnosis of prothrombic
disorder.

We found this trial at

sites

University of California San Diego Medical Center

San Diego, California 92103

from

San Diego, CA