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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: Concizumab

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02490787

NN7415-4159

U1111-1161-1501 (Other Identifier)

2014-003793-16 (EudraCT Number)

NL53826.018.15 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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