NCT00951873

A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Healthy

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII, long acting	Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
DRUG	placebo	Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
DRUG	activated recombinant human factor VII, long acting	Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-08-04
• Last updated: 2016-05-13

Locations

1 site across 1 country: United Kingdom