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This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| MEDI-557 low-dose | Active Comparator |
| |
| MEDI-557 high-dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| MEDI-557 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | The occurrence of AEs and SAEs | from time of informed consent through 360 days post dose (approximately 1 year total) |
| Safety and Tolerability | Vital sign measurements - blood pressure, heart rate, respiratory rate, temperature | Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion |
| Safety and Tolerability | Clinical lab measurements - chemistry, hematology; Urinalysis | from Day 1 (pre-dose) through 360 days post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessments - Serum | Maximum serum concentration; Time to maximum serum concentration; Terminal phase elimination half-life; Area under the serum concentration-time curve from time zero to last measurable time point; Area under the serum concentration-time curve from time zero to infinity; Clearance; Volume of distribution | 1st dose through 360 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Feldman, MD | Research Site | Principal Investigator |
| Hasan Jafri | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Miami | Florida | United States |
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| Drug |
MEDI-557 low-dose |
|
| MEDI-557 | Drug | MEDI-557 high-dose |
|
| Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash | MEDI-557 concentrations in serum and nasal wash through 360 days post dose | 1st dose through 360 days post dose |
| Pharmacokinetic Assessments - Nasal Wash | Maximum nasal wash concentration; Time to maximum nasal wash concentration; Area under the nasal wash conentration-time curve from time zero to last measurable time point | 1st dose through 360 days post dose |
| anti-RSV antibody in Serum and Nasal Wash | To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash. | 1st dose through 360 days post dose |