MEDI-557 Adult Dosing

Study Overview
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Brief Summary
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This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.

Detailed Description
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A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of MEDI-557, a Humanized Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus (RSV), Administered to Healthy Adults

Conditions
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Respiratory Syncytial Virus

Intervention / Treatment
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* Drug: Placebo
* Drug: MEDI-557
* Drug: MEDI-557


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years written informed consent obtained from subject prior to performing any protocol related procedures healthy by medical history and physical exam females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361 weight </= 110kg with a body mass index of <32kg/m2 ability to complete a follow-up period of approximately 360 days Exclusion Criteria: inability to complete a follow-up period of 360 days any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results concurrent enrollment in another clinical study employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals receipt of immunoglobulin or blood products within 60 days prior to randomziation receipt of any investigational drug therapy within 6 months prior to IP dosing clinically abnormal ECG at screening blood donation in excess of 400mL, wihtin 6 months prior to randomization previous receipt fo biologics history of immunodeficiency history of allergic disease or reactions likely to be exacerbated by any component of the IP previous medical history or evidence of interurrent illness that may compromise the safety of the subject positive lab test for Hep A, B, C or HIV pregnancy or nursing mother history of alcohol or drug abuse within past 2 years positive urine Class A drug screen acute illness within 7 days prior to randomization fever >/= 99.5F witin 7 days prior to randomization any drug therapy within 7 days prior to randomization systolic BP >150mmHG and/or diastolic BP>90mmHg receipt of vaccine within 14 days prior to randomization abnormal study labs (hem/wbc/platelet/BUN - see protocol for specific information)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: MEDI-557 low-dose<br> | Drug: MEDI-557<br>* MEDI-557 low-dose<br>|
| Active Comparator: MEDI-557 high-dose<br> | Drug: MEDI-557<br>* MEDI-557 high-dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | The occurrence of AEs and SAEs | from time of informed consent through 360 days post dose (approximately 1 year total) | 
| Safety and Tolerability | Vital sign measurements - blood pressure, heart rate, respiratory rate, temperature | Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion | 
| Safety and Tolerability | Clinical lab measurements - chemistry, hematology; Urinalysis | from Day 1 (pre-dose) through 360 days post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Assessments - Serum | Maximum serum concentration; Time to maximum serum concentration; Terminal phase elimination half-life; Area under the serum concentration-time curve from time zero to last measurable time point; Area under the serum concentration-time curve from time zero to infinity; Clearance; Volume of distribution | 1st dose through 360 days post dose | 
| Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash | MEDI-557 concentrations in serum and nasal wash through 360 days post dose | 1st dose through 360 days post dose | 
| Pharmacokinetic Assessments - Nasal Wash | Maximum nasal wash concentration; Time to maximum nasal wash concentration; Area under the nasal wash conentration-time curve from time zero to last measurable time point | 1st dose through 360 days post dose | 
| anti-RSV antibody in Serum and Nasal Wash | To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash. | 1st dose through 360 days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Syncytial Virus