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To obtain safety and tolerability information in healthy subjects is administered as a single dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: BMS-962476 SC (0.01 mg/Kg) or Placebo | Experimental | BMS-962476 0.01 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
|
| Panel 2: BMS-962476 SC (0.03 mg/Kg) or Placebo | Experimental | BMS-962476 0.03 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
|
| Panel 3: BMS-962476 SC (0.1 mg/Kg) or Placebo | Experimental | BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
|
| Panel 4: BMS-962476 SC (0.3 mg/Kg) or Placebo | Experimental | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
|
| Panel 5: BMS-962476 IV (0.3 mg/Kg) or Placebo | Experimental | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-962476 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of BMS-962476 as measured by the number of subjects with serious adverse events, deaths or discontinuations due to adverse events (AEs), AEs of injection site reactions, or potentially clinically significant changes in vital signs | Up to Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic effects of single subcutaneous (SC) and intravenous (IV) doses of BMS-962476 | Pharmacodynamic effects will be measured by fasting lipid panel | Up to Day 43 |
| Maximum observed plasma concentration (Cmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration |
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Inclusion Criteria:
Healthy population
Statin population
Exclusion Criteria:
Healthy Population
Statin population
Use of any lipid lowering medication including over the counter products (eg, niacin > 500 mg; omega-3 fatty acids > 1000 mg; red rice yeast; phytosterols or stanol esters) for lipid lowering within 30 days prior to screening visit (42 days for fibrates) with the exception of stable statin therapy in the target disease population
Prior treatment with any monoclonal antibody or investigational protein biologic within the preceding one year before study drug administration
Concurrent or use within 3 months of study drug administration of marketed or investigational systemic or inhaled corticosteroids or other immunosuppressant drugs, and within 6 weeks for topical corticosteroids
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic And Atherosclerosis Research Center/ Medpace Clinical Pharmacology | Cincinnati | Ohio | 45227 | United States |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000590930 | BMS-962476 |
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|
| Panel 6: BMS-962476 IV (1.0 mg/Kg) or Placebo | Experimental | BMS-962476 1.0 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day |
|
| Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or Placebo | Experimental | BMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
|
| Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or Placebo | Experimental | BMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day |
|
| Placebo matching with BMS-962476 | Biological |
|
| 17 time points up to Day 43 |
| Time of maximum observed plasma concentration (Tmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration | 17 time points up to Day 43 |
| Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration [AUC(0-T)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration | 17 time points up to Day 43 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration | 17 time points up to Day 43 |
| Plasma elimination half-life (T-HALF) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration | 17 time points up to Day 43 |
| Total body clearance (CL/F) of BMS-962476 SC Dosing | 15 time points up to Day 43 |
| Total body clearance (CL) of BMS-962476 IV Dosing | 17 time points up to Day 43 |
| Volume of distribution at steady state (Vss/F) of BMS-962476 SC Dosing | 15 time points up to Day 43 |
| Volume of distribution at steady state (Vss) of BMS-962476 IV Dosing | 15 time points up to Day 43 |
| Absolute bioavailability (F) of total and free BMS-962476 | 15 time points up to Day 43 |
| Frequency of anti-BMS-962476 antibodies (immunogenicity) following single SC and IV doses of BMS-962476 | Up to Day 43 |