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To evaluate the safety and tolerability of a single IV dose of MEDI-557.
The primary objective of this study is to evaluate the safety and tolerability of a single IV dose of MEDI-557 administered to healthy adult subjects in 4 dose cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single IV dose of 0.3 mg/kg MEDI-557 |
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| 2 | Experimental | Single IV dose of 3 mg/kg MEDI-557 |
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| 3 | Experimental | Single IV dose of 15 mg/kg MEDI-557 |
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| 4 | Experimental | Single IV dose of 30 mg/kg MEDI-557 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-557 | Biological | Single IV dose of 3 mg/kg |
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| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of AEs from the period immediately following study drug administration | through 28 days after dosing | |
| The occurrence of laboratory AEs from the period immediately following study drug administration | through 90 days after dosing | |
| The occurrence of SAEs from the period immediately following study drug administration | through 240 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The single-dose pharmacokinetic parameters of IV MEDI-557 and motavizumab monitored using noncompartmental analysis. | Day 240 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Pamela Griffin, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Daytona Beach | Daytona Beach | Florida | 32117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24080653 | Derived | Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30. |
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| ID | Term |
|---|---|
| C506968 | motavizumab |
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| MEDI-557 | Biological | Single IV dose of 15 mg/kg |
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| MEDI-557 | Biological | Single IV dose of 30 mg/kg |
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| MEDI-557 | Biological | Single IV dose of 0.3 mg/kg |
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