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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
42
Research Site
Miami, Florida, United States
Safety and Tolerability
The occurrence of AEs and SAEs
Time frame: 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
Time frame: Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion
Safety and Tolerability
Clinical lab measurements - chemistry, hematology; Urinalysis
Time frame: from Day 1 (pre-dose) through 360 days post dose.
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
Time frame: 1st dose through 360 days post dose
Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash
MEDI-557 concentrations in serum and nasal wash through 360 days post dose
Time frame: 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
Time frame: 1st dose through 360 days post dose
anti-RSV antibody in Serum and Nasal Wash
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To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash.
Time frame: 1st dose through 360 days post dose