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To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MEDI-524 (Numax-TM) |
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| 2 | Experimental | MEDI-524 (Numax-TM) |
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| 3 | Experimental | MEDI-524 (Numax-TM) |
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| 4 | Experimental | MEDI-524 (Numax-TM) |
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| 5 | Experimental | MEDI-524 (Numax-TM) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-524 (Numax-TM) | Biological | Grp.1: 3 mg/kg IV (single dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 30 days after patient's final dose of study drug | |
| Pharmacokinetics | Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2. | |
| Immunogenicity | 150 days after final dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Genevieve Losonsky, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SFBC International, Inc | Miami | Florida | 33181 | United States |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C506968 | motavizumab |
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| MEDI-524 (Numax-TM) |
| Biological |
Grp. 2: 15 mg/kg IV (single dose) |
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| MEDI-524 (Numax-TM) | Biological | Grp. 3: 30 mg/kg IV (single dose) |
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| MEDI-524 (Numax-TM) | Biological | Grp. 4: 3 mg/kg IM (single dose) |
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| MEDI-524 (Numax-TM) | Biological | Grp.5: 3 mg/kg IM (two doses) |
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| D014777 | Virus Diseases |
| D007239 | Infections |