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Single dose in healthy volunteers to assess bioavailability (amount of study drug in the system) between different formulations of ABT-874.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected subcutaneously in the abdominal region at a 45 degree angle |
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| Regimen B | Experimental | One 100 mg ABT-874 (pre-filled syringe liquid formulation from the 6000 L process) injected IV in an arm vein |
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| Regimen C | Experimental | One 100 mg ABT 874 (reconstituted lyophilized powder from the 3000 L process) injected subcutaneously in the abdominal region at a 45 degree angle |
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| Regimen D | Experimental | One 100 mg ABT-874 (reconstituted lyophilized powder from the 1000 L process) injected subcutaneously in the abdominal region at a 45 degree angle |
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| Regimen E | Experimental | 700 mg ABT-874 (reconstituted lyophilized powder from the 3000 L process) in 100 mL 5% dextrose solution IV infusion in an arm vein |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-874 | Drug | See Arm Description for details regarding specific Intervention Description that is attributed to each Arm, respectively. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability following single dose | Hours: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 1008, 1344 for Regimens A, C, D and additional hours 4 & 8 for Regimen B and hours 0.5 and 6 hours for Regimen E |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study | Through Day 85 (and / or 45 days after study drug stoppped) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin Valdes, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator # 16001 | Evansville | Indiana | 47710 | United States |
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| ID | Term |
|---|---|
| C544528 | briakinumab |
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