Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled, Single Centre, Single Dose Trial, Assessing the Pharmacokinetics of NNC172-2021, Administered Subcutaneously at Two Different Dose Levels, in Healthy Japanese Subjects

Conditions
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Healthy, Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Intervention / Treatment
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* Drug: NNC172-2021
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC172-2021 low dose / Placebo<br> | Drug: NNC172-2021<br>* One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL<br>Drug: placebo<br>* One injection administered subcutaneously (s.c., under the skin)<br>|
| Experimental: NNC172-2021 high dose / Placebo<br> | Drug: NNC172-2021<br>* One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL<br>Drug: placebo<br>* One injection administered subcutaneously (s.c., under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021 |  | Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal concentration of NNC172-2021 (Cmax) |  | Week 5 | 
| Time point for maximal concentration (tmax) |  | Week 5 | 
| Terminal half-life (t1/2) |  | Week 5 | 
| Number of adverse events (AEs) |  | Week 5 | 
| Presence of antibodies against NNC172-2021 |  | 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 |