This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI4893, an extended half-life human monoclonal antibody against Staphylococcus aureus alpha toxin, in healthy adult subjects. Approximately 33 subjects will be enrolled across 4 fixed dose cohorts at 1 study site . This study will last approximately 389 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 360 day safety follow up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
85
Research Site
Miami, Florida, United States
The occurence of adverse events and serious adverse events.
Time frame: From the time of informed consent through 360 days post dose
Vital Sign Measurements
blood pressure, heart rate, respiratory rate, temperature
Time frame: Pre-dose through Study Day 15
Clinical Safety lab measurements
Chemistry, Hematology and urinalysis
Time frame: from Day 1 (pre-dose) through 90 days post dose
Pharmacokinetic Assessments - Serum
MEDI4893 Pharmacokinetic parameters.
Time frame: Pre-dose through 360 days post dose
Anti Drug Antibody (ADA) Assessments - Serum
ADA responses to MEDI4893.
Time frame: Pre-dose through 360 days post dose
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