Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

• Status: Completed
• Trial end date: 2016-10-14
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted globally. 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 concizumab administered subcutaneously to haemophilia A subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand

• Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records

• Age between 18 and 64 years both inclusive, at the time of signing informed consent

• Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product or related products

• Platelet count below 50x10^9/L at screening

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

• Subjects at increased risk of cardiovascular disease as judged by the investigator