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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012032-32 | EudraCT Number |
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The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - BMS-844421 | Experimental |
| |
| Arm 2 - 0.9% sodium chloride injection solution | Placebo Comparator |
| |
| Arm 3 - BMS-844421 | Experimental |
| |
| Arm 4 - 0.9% sodium chloride injection solution | Placebo Comparator |
| |
| Arm 5 - BMS-844421 | Experimental |
| |
| Arm 6 - 0.9% sodium chloride injection solution | Placebo Comparator |
| |
| Arm 7 - BMS-844421 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-844421 | Drug | Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations | At the conclusion of the MAD part of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Assess single and multiple dose pharmacokinetics of BMS-844421 | All outcomes will be assessed at the conclusion of the MAD part of the study | |
| Assess the absolute bioavailability of single BMS-844421 SC doses | All outcomes will be assessed at the conclusion of the MAD part of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Berlin | 14050 | Germany |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Arm 8 - 0.9% sodium chloride injection solution | Placebo Comparator |
|
| Arm 9 - BMS-844421 | Experimental |
|
| Arm 10 - 0.9% sodium chloride injection solution | Placebo Comparator |
|
| Arm 11 - BMS-844421 | Experimental |
|
| Arm 12 - 0.9% sodium chloride injection solution | Placebo Comparator |
|
| Arm 13 - BMS-844421 | Experimental |
|
| Arm 14 - 0.9% sodium chloride injection solution | Placebo Comparator |
|
| Arm 15 - BMS-844421 | Experimental |
|
| Arm 16 - 0.9% sodium chloride injection solution | Placebo Comparator |
|
| 0.9% sodium chloride injection solution | Drug | Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days |
|
| Assess the effects of multiple doses of BMS-844421on lipid components | All outcomes will be assessed at the conclusion of the MAD part of the study |
| D006949 |
| Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |