| Primary | Incidence of Adverse Events | Number of participants experiencing adverse events (includes both adverse events and serious adverse events) | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina) | Posted | | Number | | Participants | | Days 0 - 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Primary | Incidence of Abnormal Troponin Levels | Number of participants with troponin levels greater than upper limit of normal | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina) | Posted | | Number | | Participants | | Days 0, 1, 7, 14, and 28 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Primary | Incidence of Clinically Significant Changes From Baseline in Neurologic Exam | Number of participants with clinically significant changes from baseline in neurologic exam | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina) | Posted | | Number | | Participants | | Days 0, 7, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Primary | Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain | Number of participants with changes from baseline in the Day 28 MRI of the brain | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina) | Posted | | Number | | Participants | | Days 0 and 28 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Primary | Incidence of Serious Adverse Events | Number of participants experiencing serious adverse events | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina) | Posted | | Number | | Participants | | Days 0 - 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Incidence of Anti-drug Antibodies (ADA) to MEDI-528 | Number of participants with ADA to MEDI-528 | All subjects who received MEDI-528 (no safety or ADA information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Partial ADA information was available in the 0.3 mg/kg group (Day 0 and 14, n=5; Day 28, n=2; Day 42 and 84, n = 0) | Posted | | Number | | Participants | | Days 0, 14, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Time to Observed Maximum Serum Concentration (Tmax) | | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Days | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Observed Maximum Serum Concentration (Cmax) | | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Micrograms per milliliter | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] | | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Micrograms times day per milliliter | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528 | AUC(0-infinity) of MEDI-528 | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Microgram times day per milliliter | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] | | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Percent | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Total Body Clearance (CL) | | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Liter per day | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Half-life (T1/2) | | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Days | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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| Secondary | Apparent Extravascular Terminal Phase Volume of Distribution (Vz/F) | | All subjects who received MEDI-528 (no safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina). Two subjects in the 0.3 mg/kg group had no blood samples for pharmacokinetic analysis. | Posted | | Mean | Standard Deviation | Liters | | Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84 | | | | ID | Title | Description |
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| OG000 | MEDI-528 0.3 mg/kg | MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose | | OG001 | MEDI-528 1 mg/kg | MEDI-528 (1 mg/kg) administered as a single, SC dose | | OG002 | MEDI-528 3 mg/kg | MEDI-528 (3 mg/kg) administered as a single, SC dose | | OG003 | MEDI-528 9 mg/kg | MEDI-528 (9 mg/kg) administered as a single, SC dose |
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