Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2003

Primary Completion Date

August 31, 2003

Study Completion Date

August 31, 2003

Conditions
Congenital Bleeding DisorderCongenital FXIII DeficiencyHealthy
Interventions
DRUG

catridecacog

For 5 consecutive days, one daily dose of rFXIII was administered intravenously (IV) to eight subjects in each dose group (10 or 25 U/kg).

DRUG

placebo

For 5 consecutive days, one daily dose of placebo was administered intravenously (IV) to two subjects in each dose group (10 or 25 U/kg).

Trial Locations (1)

SL1 2 AD

Berkshire

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY