NCT01847989

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (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 escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Conditions

• Congenital Bleeding Disorder
• Congenital FXIII Deficiency
• Healthy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2003-01-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2013-05-07
• Last updated: 2017-01-11

Locations

1 site across 1 country: United Kingdom