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MEDI-557 Adult Dosing

NCT ID: NCT01562938

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

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.

Conditions

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Respiratory Syncytial Virus

Keywords

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Respiratory Syncytial Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

MEDI-557 low-dose

Group Type ACTIVE_COMPARATOR

MEDI-557

Intervention Type DRUG

MEDI-557 low-dose

MEDI-557 high-dose

Group Type ACTIVE_COMPARATOR

MEDI-557

Intervention Type DRUG

MEDI-557 high-dose

Interventions

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Placebo

Placebo

Intervention Type DRUG

MEDI-557

MEDI-557 low-dose

Intervention Type DRUG

MEDI-557

MEDI-557 high-dose

Intervention Type DRUG

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Research Site

Hasan Jafri

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Research Site

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CD-ID-MEDI-557-1092

Identifier Type: -

Identifier Source: org_study_id