A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

• Status: Terminated
• Trial end date: 2012-09-04
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product(s) or related products

• Thrombocyte count below the lower limit of normal range at screening

• Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator