A Single-centre, Randomised, Double-blind, Single Dose, Cross-over Trial Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021, Following Intravenous Administration in Healthy Male Subjects

NCT01272206 Phase 1 COMPLETED

This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2011-01
Completion	2011-03

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B

Interventions

• NNC 0128-0000-2011
• NNC 0128-0000-2021

Primary outcomes

• Frequency of adverse events (AEs) — from first trial product administration until maximally 10 weeks after last trial product administration

Countries

United Kingdom