Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1 Double-blind, Single-dose, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults

Conditions
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Influenza

Intervention / Treatment
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* Drug: MEDI8852
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 through 65 years at the time of screening Weight ≥ 45 kg and ≤ 110 kg at screening Healthy by medical history, physical examination, and baseline safety laboratory studies. Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening Electrocardiogram without clinically significant abnormalities at screening Able to complete the follow-up period through Day 101 as required by the protocol Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 28 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study Exclusion Criteria: Acute illness, including fever > 99.5°F, on day prior to or day of planned dosing Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine. and other nutritional supplements that have not been taken for at least 30 days prior to enrollment, are not exclusionary. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening Receipt of immunoglobulin or blood products within 6 months prior to screening Receipt of any vaccine within 14 days prior to investigational product dosing or planned receipt of any influenza vaccine within 100 days after investigational product dosing Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above the upper limit of normal or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years Pregnant or nursing mother History of alcohol or drug abuse within the past 2 years tha OR positive Class A drug screen for amphetamines, barbiturates, opiates, or cocaine at screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDI8852<br>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. | Drug: MEDI8852<br> <br> |
| Placebo Comparator: Placebo<br>Solution containing no active ingredients | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Flu, Flu A, Influenza A