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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI8852 | Experimental | MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) supplied as 50 mg/mL solution for infusion. MEDI8852 is being evaluated for treatment of patients hospitalized with influenza A. |
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| Placebo | Placebo Comparator | Solution containing no active ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI8852 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 28 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½) | This variable will be estimated for MEDI8852 in the IV cohorts where the data allow. | 100 days postdose |
| Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28844541 | Derived | Mallory RM, Ali SO, Takas T, Kankam M, Dubovsky F, Tseng L. A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers. Biologicals. 2017 Nov;50:81-86. doi: 10.1016/j.biologicals.2017.08.007. Epub 2017 Aug 23. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000627863 | MEDI8852 |
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This variable will be estimated for MEDI8852 in the IV cohorts where the data allows.
| 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. | 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. | 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. | 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. | 100 days postdose |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |