The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects.
This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV). A total of 4 different dose levels of investigational product will be evaluated across the cohorts. Subjects will be followed for approximately 100 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
Research Site
Overland Park, Kansas, United States
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.
Time frame: 100 days postdose
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)
Time frame: 28 days postdose
Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allows.
Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: area under the concentration time curve from 0 to t (AUC 0-t) and from 0 to infinity (AUC 0-inf)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Time frame: 100 days postdose
Incidence of anti-drug antibody to MEDI8852 in serum
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
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Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Time frame: 100 days postdose