Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief 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.
Interventions
DRUGConcizumab
Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
DRUGplacebo
Administered subcutaneously (s.c., under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events (AEs) | From first trial drug administration (day 1) to 11 weeks after the first trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| Trough level of concizumab | Prior to the last s.c. dose administration (day 42) |
| Frequency of binding non-neutralizing anti-concizumab antibodies | From first trial drug administration (day 1) to 11 weeks after the first trial product administration |
Countries
Australia, Austria, Croatia, France, Germany, Israel, Malaysia, Netherlands, Poland, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed