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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1292-7153 | Other Identifier | Universal Trial Number | |
| 2023-506520-90 | Other Identifier | EU CT Number |
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This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study consists of three parts: single ascending dose (SAD), multiple ascending dose (MAD) and single subcutaneous dose (SSD). Each part will have more than one cohort (like sub-parts). No matter which part the participants will be enrolled in, they will either get the study medicine (Inno8) or a dummy medicine that looks like the study medicine but has no effect on the body (placebo). Which treatment participants get is decided by chance. The study medicine is a new medicine that cannot be prescribed by doctors. In the SAD and SSD part participants will receive a single injection of study medicine or placebo, and the study will last for up to 9 weeks. In the MAD part, participants will receive 1-2 tablets of study medicine or placebo daily for 10 days, and the study will last for up to 11 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (SAD): NNC0442-0344 A | Experimental | Participants will receive single dose of NNC0442-0344 A intravenously. |
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| Cohort 2 (SAD): NNC0442-0344 A | Experimental | Participants will receive single dose of NNC0442-0344 A intravenously. |
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| Cohort 3 (SAD): NNC0442-0344 A | Experimental | Participants will receive single dose of NNC0442-0344 A intravenously. |
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| Cohort 4 (SAD): NNC0442-0344 A | Experimental | Participants will receive single dose of NNC0442-0344 A intravenously. |
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| Cohort 5 (SAD): NNC0442-0344 A | Experimental | Participants will receive single dose of NNC0442-0344 A intravenously. |
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| Cohort 1 (MAD): NNC0442-0344 A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0442-0344 A | Drug | SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously. |
| Measure | Description | Time Frame |
|---|---|---|
| SAD: Number of treatment emergent adverse events | Measured as count of events. | From time of dosing (Day 1) to Day 36 |
| MAD: Number of treatment emergent adverse events | Measured as count of events. | From time of dosing (Day 1) to end of follow-up (Day 46) |
| SSD: Number of treatment emergent adverse events | Measured as count of events. | From time of dosing (Day 1) to Day 36 |
| Measure | Description | Time Frame |
|---|---|---|
| SAD: Change in D-dimer | Measured as absolute and percentage (%). | From baseline (Day 1) to Day 36 |
| SAD: Change in prothrombin fragment 1 and 2 | Measured as absolute and %. |
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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 | |||
| Charité Research Organisation GmbH |
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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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Participants will receive a oral daily dose of NNC0442-0344 A for 10 days.
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| Cohort 2 (MAD): NNC0442-0344 A | Experimental | Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. |
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| Cohort 3 (MAD): NNC0442-0344 A | Experimental | Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. |
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| Cohort 4 (MAD): NNC0442-0344 A | Experimental | Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. |
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| Cohort 1 (SSD): NNC0442-0344 A | Experimental | Participants will receive single dose of NNC0442-0344 A subcutaneously. |
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| Cohort 2 (SSD): NNC0442-0344 A | Experimental | Participants will receive single dose of NNC0442-0344 A subcutaneously. |
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| SAD: Placebo | Placebo Comparator | Participants will receive single dose of placebo intravenously. |
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| MAD: Placebo | Placebo Comparator | Participants will receive a oral daily dose of Placebo for 10 days. |
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| SSD: Placebo | Placebo Comparator | Participants will receive single dose of placebo subcutaneously. |
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| Placebo | Drug | SAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously. |
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| From baseline (Day 1) to Day 36 |
| SAD: Change in fibrinogen | Measured as absolute and %. | From baseline (Day 1) to Day 36 |
| SAD: Change in platelets | Measured as absolute and %. | From baseline (Day 1) to Day 36 |
| SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose | Measured as nanograms per millilitre (ng/mL). | From baseline (Day 1) to Day 36 |
| SAD: AUC, SD: the area under the concentration curve of Inno8 after a single dose | Measured as nanograms*day per millilitre (ng*day/mL). | From baseline (Day 1) to Day 36 |
| SAD: T1/2, SD: the terminal half-life of Inno8 after a single dose | Measured as days. | From baseline (Day 1) to Day 36 |
| SAD: Maximum change in activated partial thromboplastin time | Measured as seconds. | From baseline (Day 1) to Day 36 |
| SAD: Maximum thrombin generation (peak height) | Measured as nanomolar (nM). | From baseline (Day 1) to Day 36 |
| MAD: Change in D-dimer | Measured as absolute and %. | From baseline (Day 1) to Day 46 |
| MAD: Change in prothrombin fragment 1 and 2 | Measured as absolute and %. | From baseline (Day 1) to Day 46 |
| MAD: Change in fibrinogen | Measured as absolute and %. | From baseline (Day 1) to Day 46 |
| MAD: Change in platelets | Measured as absolute and %. | From baseline (Day 1) to Day 46 |
| MAD: Occurrence of anti-Inno8 antibodies | Measured as count. | From baseline (Day 1) to Day 46 |
| MAD: Cmax: The maximum concentration of Inno8 after multiple doses | Measured as ng/mL. | From Day 10 to Day 11 |
| MAD: Tmax: The time to Cmax after last multiple dose | Measured as hours. | From Day 10 to Day 11 |
| MAD: Tmax: The time to Cmax after first dose | Measured as hours. | From Day 1 to Day 2 |
| MAD: AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses | Measured as ng*day/mL. | From Day 10 to Day 11 |
| MAD: Maximum thrombin generation (peak height) | Measured as nM. | From Day 10 to Day 11 |
| SSD: Change in D-dimer | Measured as absolute and %. | From baseline (Day 1) to Day 36 |
| SSD: Change in prothrombin fragment 1 and 2 | Measured as absolute and %. | From baseline (Day 1) to Day 36 |
| SSD: Change in fibrinogen | Measured as absolute and %. | From baseline (Day 1) to Day 36 |
| SSD: Change in platelets | Measured as absolute and %. | From baseline (Day 1) to Day 36 |
| SSD: Cmax, SD: the maximal concentration of Inno8 after a single dose | Measured as ng/mL. | From baseline (Day 1) to Day 36 |
| SSD: AUC, SD: the area under the concentration curve of Inno8 after a single dose | Measured as ng*day/mL. | From baseline (Day 1) to Day 36 |
| SSD: T1/2, SD: the terminal half-life of Inno8 after a single dose | Measured as days. | From baseline (Day 1) to Day 36 |
| SSD: Maximum change in activated partial thromboplastin time | Measured as seconds. | From baseline (Day 1) to Day 36 |
| SSD: Maximum thrombin generation (peak height) | Measured as nanomolar (nM). | From baseline (Day 1) to Day 36 |
| Berlin |
| 10117 |
| Germany |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |