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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| MEDI4893 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| MEDI4893 |
| Measure | Description | Time Frame |
|---|---|---|
| The occurence of adverse events and serious adverse events. | From the time of informed consent through 360 days post dose | |
| Vital Sign Measurements | blood pressure, heart rate, respiratory rate, temperature | Pre-dose through Study Day 15 |
| Clinical Safety lab measurements | Chemistry, Hematology and urinalysis | from Day 1 (pre-dose) through 90 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessments - Serum | MEDI4893 Pharmacokinetic parameters. | Pre-dose through 360 days post dose |
| Anti Drug Antibody (ADA) Assessments - Serum | ADA responses to MEDI4893. |
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Inclusion Criteria:
Exclusion Criteria:
Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
Acute illness at study entry.
Fever 99.5F or higher on day of dosing.
Any drug therapy within 7 days prior to Day 1.
Blood donation in excess of 400 mL within 6 months prior to study entry.
Receipt of immunoglobulin or blood products within 6 months prior to study entry.
Receipt of any prior investigational drug or investigational vaccine within 120 days prior to investigational product dosing or planned dosing
Receipt of any standard vaccine within 14 days prior to investigational product dosing.
Previous receipt of a monoclonal antibody.
Receipt of immunosuppressive medications in the prior year or any active or prior history of immunodeficiency. Any course of systemic corticosteroids of more than 7 day duration during the prior year excludes a subject.
History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
Previous medical history or evidence of an intercurrent illness that may compromise the safety of the subject in the study.
Evidence of any systemic disease on physical examination at screening.
Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) at screening.
Any of the following at screening:
Pregnant or nursing mother.
Active alcohol or drug abuse or history of alcohol or drug abuse that, in the opinion of the principal investigator, might compromise subject safety, study safety assessments, or ability of subject to comply with study requirements.
Concurrent enrollment in another interventional study.
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| Name | Affiliation | Role |
|---|---|---|
| Howard Schwartz, M.D. | Research Site | Principal Investigator |
| Hasan Jafri, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Miami | Florida | United States |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000600718 | suvratoxumab |
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| Drug |
Human immunoglobulin G1 kappa monoclonal antibody |
|
|
| Pre-dose through 360 days post dose |