NCT01848002

Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

A Randomized, Placebo-Controlled, Double-Blind, Multi-dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Conditions

• Congenital Bleeding Disorder
• Congenital FXIII Deficiency
• Healthy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2003-05-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2013-05-07
• Last updated: 2013-11-26

Locations

1 site across 1 country: United Kingdom