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A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prefilled Syringe Upper Arm | Experimental | Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699 |
|
| Prefilled Syringe Thigh | Experimental | Single subcutaneous dose from prefilled syringe into thigh of BMS-931699 |
|
| Prefilled Syringe Abdomen | Experimental | Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699 |
|
| Drug in Vial Upper Arm | Experimental | Single subcutaneous dose from drug in vial into upper arm of BMS-931699 |
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| Drug in Vial Thigh | Experimental | Single subcutaneous dose from drug in vial into thigh of BMS-931699 |
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| Drug in Vial Abdomen | Experimental | Single subcutaneous dose from drug in vial into abdomen of BMS-931699 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-931699 | Drug | BMS-931699 single subcutaneous dose on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants | 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of BMS-931699 following a single prefilled syringe or drug in vial subcutaneous dose in healthy participants by assessing adverse events and other physical assessments throughout study conduct | 43 days |
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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 |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C000604694 | lulizumab pegol |
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