NCT01288391

Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients

An Open Non-randomised Dose Escalation Trial Investigating the Safety and Pharmacokinetics of Single Intravenous Administrations of NNC128-0000-2011 in Patients With Haemophilia A or B

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B

Interventions

Type	Name	Description
DRUG	NNC 0128-0000-2011	Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
DRUG	NNC 0128-0000-2011	Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-02-02
• Last updated: 2016-05-13

Locations

3 sites across 3 countries: Germany, Japan, Spain