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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003283-20 | EudraCT Number |
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Investigate the safety, tolerability and pharmacokinetics of BAY1093884 after Intravenous (IV) and subcutaneous (SC) administration of increasing single doses and SC administration of multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without inhibitors | Experimental | Dose escalation steps for participants without inhibitors - intravenous infusion and subcutaneous injection |
|
| With inhibitors | Experimental | Dose escalation steps for participants with inhibitors - intravenous infusion and subcutaneous injection |
|
| Without inhibitors_multiple dose | Experimental | Multiple dose cohort for participants without inhibitors - a single subcutaneous injection once a week for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1093884 | Drug | Single escalating dose with a starting dose of 0.3 mg/kg for the first cohort. Drug will be administered via IV infusion over 1 hour and SC injection. Based on safety, PK and PD results the doses for the other cohorts will be determined. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants (single dose cohors) with adverse events as measure of safety and tolerability | Adverse events including abnormal laboratory findings and local injection site reactions | Up to 56 days |
| Plasma levels of anti-BAY1093884 antibodies | Pre-dose, Day 14, 21,28, 43 and 56 | |
| Plasma concentration of BAY1093884 characterized by AUC(0-tlast) | AUC from time 0 to the last data point > LLOQ (lower limit of quantitation) | Day 0 [pre-dose (within 1 hour), at the end of infusion or injection (=1hr), 2hrs, 4hrs, 8hrs], Days 1, 3, 5, 7, 14, 21, 28, 43, and 56 (for cohorts 3, 4 and I-SC2, S-2, S-3) after the start of infusion |
| Plasma concentration of BAY1093884 characterized by AUC(0-tlast)/D | AUC(0-last) divided by dose | Day 0 [pre-dose (within 1 hour), at the end of infusion or injection (=1hr), 2hrs, 4hrs, 8hrs], Days 1, 3, 5, 7, 14, 21, 28, 43, and 56 (for cohorts 3, 4 and I-SC2, S-2, S-3) after the start of infusion |
| Plasma concentration of BAY1093884 characterized by Cmax | Maximum observed drug concentration in measured matrix after single dose administration | Day 0 [pre-dose (within 1 hour), at the end of infusion or injection (=1hr), 2hrs, 4hrs, 8hrs], Days 1, 3, 5, 7, 14, 21, 28, 43, and 56 (for cohorts 3, 4 and I-SC2, S-2, S-3) after the start of infusion |
| Plasma concentration of BAY1093884 characterized by Cmax/D | Cmax divided by dose | Day 0 [pre-dose (within 1 hour), at the end of infusion or injection (=1hr), 2hrs, 4hrs, 8hrs], Days 1, 3, 5, 7, 14, 21, 28, 43, and 56 (for cohorts 3, 4 and I-SC2, S-2, S-3) after the start of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue factor pathway inhibitor (TFPI) activity | Up to 77 days | |
| Number of participants (multiple dose cohort) with adverse events as a measure of safety and tolerability | Adverse events including abnormal laboratory findings and local injection site reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plovdiv | 4002 | Bulgaria | ||||
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| BAY1093884 | Drug | Multiple dose cohort with a single 150-mg SC injection once a week for 6 weeks. |
|
| Up to 77 days |
| Plasma levels of anti-BAY1093884 antibodies (multiple dose cohort) | Pre-dose, Day 14, 28, 49 and 77 |
| Plasma concentration of BAY1093884 characterized by AUC(0-7d and AUC(0-tau) (multiple dose cohort) | AUC from time 0 to 7d after first and last dose (AUC(0-tau) | Day 0 (prior to start of SC injection) and 8 hrs after start of SC injection, Days 1, 3, 5 and Days 7, and Day 35 (prior to start of SC injection) and 8 hrs after start of SC injection on Day 35; Days 36, 38, 40, 42 |
| Plasma concentration of BAY1093884 characterized by AUC(0-7d/D and AUC(0-tau)/D after multiple dose | AUC(0-7d) after first dose and AUC(0-tau) after last dose divided by dose | Day 0 (prior to start of SC injection) and 8 hrs after start of SC injection, Days 1, 3, 5 and Days 7, and Day 35 (prior to start of SC injection) and 8 hrs after start of SC injection on Day 35; Days 36, 38, 40, 42 |
| Plasma concentration of BAY1093884 characterized by Cmax after first dose and last dose (Cmax,md) | maximum observed drug concentration in measured matrix after first and last dose | Day 0 (prior to start of SC injection) and 8 hrs after start of SC injection, Days 1, 3, 5 and Days 7, and Day 35 (prior to start of SC injection) and 8 hrs after start of SC injection on Day 35; Days 36, 38, 40, 42 |
| Plasma concentration of BAY1093884 characterized by Cmax/D after first dose and last dose (Cmax,md/D) | Cmax after first and last dose divided by dose | Day 0 (prior to start of SC injection) and 8 hrs after start of SC injection, Days 1, 3, 5 and Days 7, and Day 35 (prior to start of SC injection) and 8 hrs after start of SC injection on Day 35; Days 36, 38, 40, 42 |
| Accumulation of BAY 1093884 in plasma as defined by ratio for Cmax and AUC (after first and last dose) | Cmax after last dose divided by Cmax after first dose, AUC after last dose divided by AUC after first dose | Day 0 (prior to start of SC injection) and 8 hrs after start of SC injection, Days 1, 3, 5 and Days 7, and Day 35 (prior to start of SC injection) and 8 hrs after start of SC injection on Day 35; Days 36, 38, 40, 42 |
| Sofia |
| 1756 |
| Bulgaria |
| Varna | 9010 | Bulgaria |
| Giessen | Hesse | 35392 | Germany |
| Berlin | 10249 | Germany |
| Suginami | Tokyo | 167-0035 | Japan |
| Kiev | Ukraine |
| Lviv | 79044 | Ukraine |
| London | NW3 2QG | United Kingdom |
| Manchester | M13 9WL | United Kingdom |
| 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 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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