MEDI-557 Adult Dosing

Completed · Phase 1 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus

In brief

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.

Key facts

Study ID

NCT01562938

Run by

MedImmune LLC

People needed

42

Starts

2012-03-01

Expected to finish

2013-07-01

Last updated by the study team

2013-10-07

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-45 years
• 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

You may not qualify if…

• 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)

Where it is running

• Research Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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