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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004575-36 | EudraCT Number | ||
| U1111-1124-5137 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC172-2021 low dose / Placebo | Experimental |
| |
| NNC172-2021 high dose / Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC172-2021 | Drug | One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021 | Week 5 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Harrow | HA1 3UJ | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| placebo | Drug | One injection administered subcutaneously (s.c., under the skin) |
|
| 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 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |