Respiratory Syncytial Virus Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult subjects.
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult subjects. Approximately 136 subjects will be entered to receive treatment across 5 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. A total of 4 different dose levels of investigational product will be evaluated across the 5 cohorts. Subjects will be followed for approximately 1 year. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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