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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.
Condition or disease
Respiratory Syncytial Virus
Drug: PlaceboDrug: MEDI-557
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.
A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of MEDI-557, a Humanized Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus (RSV), Administered to Healthy Adults
Pharmacokinetic Assessments - Serum [ Time Frame: 1st dose through 360 days post dose ]
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
Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash [ Time Frame: 1st dose through 360 days post dose ]
MEDI-557 concentrations in serum and nasal wash through 360 days post dose
Pharmacokinetic Assessments - Nasal Wash [ Time Frame: 1st dose through 360 days post dose ]
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
anti-RSV antibody in Serum and Nasal Wash [ Time Frame: 1st dose through 360 days post dose ]
To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash.
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
written informed consent obtained from subject prior to performing any protocol related procedures
healthy by medical history and physical exam
females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug
nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361
weight </= 110kg with a body mass index of <32kg/m2
ability to complete a follow-up period of approximately 360 days
inability to complete a follow-up period of 360 days
any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results
concurrent enrollment in another clinical study
employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals
receipt of immunoglobulin or blood products within 60 days prior to randomziation
receipt of any investigational drug therapy within 6 months prior to IP dosing
clinically abnormal ECG at screening
blood donation in excess of 400mL, wihtin 6 months prior to randomization
previous receipt fo biologics
history of immunodeficiency
history of allergic disease or reactions likely to be exacerbated by any component of the IP
previous medical history or evidence of interurrent illness that may compromise the safety of the subject
positive lab test for Hep A, B, C or HIV
pregnancy or nursing mother
history of alcohol or drug abuse within past 2 years
positive urine Class A drug screen
acute illness within 7 days prior to randomization
fever >/= 99.5F witin 7 days prior to randomization
any drug therapy within 7 days prior to randomization
systolic BP >150mmHG and/or diastolic BP>90mmHg
receipt of vaccine within 14 days prior to randomization
abnormal study labs (hem/wbc/platelet/BUN - see protocol for specific information)