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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1277-9765 | Other Identifier | World Health Organization (WHO) | |
| 2022-002318-18 | EudraCT Number |
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Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe and cartridge. The new pen injector is intended to facilitate the administration of Mim8 for patients with haemophilia A. The participants will get Mim8 as injection under the skin (subcutaneously) of the belly using the DV3407-C1 pen injector and a needle (hereinafter referred to as pen injector) or using a needle and syringe from a cartridge (hereafter called syringe and cartridge). The participants will receive one injection with Mim8, either with the DV3407-C1 pen injector or with a syringe and cartridge. The study participation will last up to 20 weeks. Only healthy men can take part in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Pilot part) | Experimental | Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector. |
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| Arm 2 (Pilot part) | Experimental | Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge. |
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| Arm 3 (Bioequivalence part) | Experimental | Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector. |
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| Arm 4 (Bioequivalence part) | Experimental | Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0365-3769 (Mim8) | Drug | Participants will receive a single dose of Mim8 subcutaneously in the abdomen. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose | Measured in micrograms*day per milliliter (μg*day/mL). | From time of dosing (day 1) to day 113 |
| Cmax, SD: maximum plasma concentration of Mim8 after a single dose | Measured in μg/mL. | From time of dosing (day 1) to day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf, SD: area under the Mim8 plasma concentration-time curve from time 0 to infinity after a single | Measured in μg*day/mL. | From time of dosing (day 1) to day 113 |
| t1/2, SD: the terminal half-life of Mim8 after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Campus Charité Mitte - Charité Research Organisation GmbH | Berlin | 10117 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The study consists of two parts - an open-label pilot part and a double-blind bioequivalence part.
Measured in days.
| From time of dosing (day 1) to day 113 |
| tmax, SD: the time to maximum concentration of Mim8 after a single dose | Measured in days. | From time of dosing (day 1) to day 113 |
| Number of injection site reactions | Measured in count of events. | From time of dosing (day 1) to day 113 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |