Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects.
Interventions
DRUGNNC172-2021
One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL
DRUGplacebo
One injection 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
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male Japanese subjects defined as: Subjects born in Japan, time residing outside of Japan does not exceed 5 years, both parents and all 4 grandparents of Japanese descent * Body weight between 50 and 100 kg, both inclusive * Body mass index (BMI) between 18.0 and 30.0 kg/m\^2, both inclusive
Exclusion criteria
* Male subjects who are sexually active and not surgically sterilised who, or whose partner, are unwilling to use two different forms of effective contraception, one of which has to be a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication * Planned surgery 30 days prior to trial product administration and/or during the entire trial period * Known hepatic dysfunction during the last 12 months prior to screening (Visit 1) * Positive urine test for drugs of abuse * Active hepatitis B and/or hepatitis C infection * Positive for human immunodeficiency virus (HIV) * Subjects with clinical signs of thromboembolic events, considered to be at high risk of thromboembolic event or subjects with a known first degree family history of thromboembolism * Participation in any other trial investigating other products or involving blood sampling within the last 30 days prior to screening * Use of non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (ASA), but not ibuprofen and cyclooxygenase-2 (COX-2) specific inhibitors within 2 weeks prior to trial product administration (Visit 2) * Positive alcohol test at screening (Visit 1) and/or history of alcohol or drug abuse within the last 12 months prior to screening (Visit 1) * Smokers; defined as tobacco users smoking more than 5 cigarettes per day or the corresponding amount of tobacco consumption * Blood donation within the last 3 months prior to screening and/or during the entire trial period * Strenuous exercise (as judged by the trial physician) within the last 4 days prior to screening (Visit 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021 | Week 5 |
Secondary
| Measure | Time frame |
|---|---|
| Time point for maximal concentration (tmax) | Week 5 |
| Terminal half-life (t1/2) | Week 5 |
| Number of adverse events (AEs) | Week 5 |
| Maximal concentration of NNC172-2021 (Cmax) | Week 5 |
| Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation | Week 5 |
| TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA) | Week 5 |
| Presence of antibodies against NNC172-2021 | Week 5 |
Countries
United Kingdom
Outcome results
None listed