NCT01847989 - Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

May 31, 2003

Study Completion Date

May 31, 2003

Conditions

Congenital Bleeding DisorderCongenital FXIII DeficiencyHealthy

Interventions

DRUG

catridecacog

Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

DRUG

placebo

Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

Trial Locations (1)

Novo Nordisk Investigational Site, Berkshire