A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||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|
- The occurence of adverse events and serious adverse events. [ Time Frame: From the time of informed consent through 360 days post dose ] [ Designated as safety issue: Yes ]
- Vital Sign Measurements [ Time Frame: Pre-dose through Study Day 15 ] [ Designated as safety issue: Yes ]blood pressure, heart rate, respiratory rate, temperature
- Clinical Safety lab measurements [ Time Frame: from Day 1 (pre-dose) through 90 days post dose ] [ Designated as safety issue: Yes ]Chemistry, Hematology and urinalysis
- Pharmacokinetic Assessments - Serum [ Time Frame: Pre-dose through 360 days post dose ] [ Designated as safety issue: Yes ]MEDI4893 Pharmacokinetic parameters.
- Anti Drug Antibody (ADA) Assessments - Serum [ Time Frame: Pre-dose through 360 days post dose ] [ Designated as safety issue: Yes ]ADA responses to MEDI4893.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Other Name: Placebo
|Active Comparator: MEDI4893||
Human immunoglobulin G1 kappa monoclonal antibody
Other Name: Active comparator
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.
|United States, Florida|
|Miami, Florida, United States|
|Principal Investigator:||Howard Schwartz, M.D.||Research Site|
|Study Director:||Hasan Jafri, M.D.||MedImmune LLC|