A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

June 30, 2012

Study Completion Date

July 31, 2012

Conditions
Healthy
Interventions
BIOLOGICAL

rVIIa-FP

Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.

BIOLOGICAL

Placebo (0.9% normal saline)

Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.

Trial Locations (1)

Unknown

Phase I Unit, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY