Randomized, Double-blind, Placebo Controlled Phase II Study to Examine the Effects of DAS181 in Healthy Adult Subjects With Laboratory Confirmed Influenza



Status:Archived
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2009

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This protocol will seek to enroll adult otherwise healthy subjects presenting with
influenza-like illness (ILI). Subjects will enter the study based on listed
inclusion/exclusion criteria, including a positive diagnostic test for influenza virus
(IFV).


This protocol will seek to enroll adult otherwise healthy subjects presenting with
influenza-like illness (ILI). Subjects will enter the study based on listed
inclusion/exclusion criteria, including a positive diagnostic test for influenza virus
(IFV).

Based upon a Rapid Diagnostic Test of IFV, subjects will be randomized into one of three
groups: a single dose DAS181 10 mg group, a multiple dose DAS181 10 mg, 10 mg, 10 mg dose
group or a placebo group.

The full analysis set will include subjects with confirmed influenza as documented with
Rapid Diagnostic Testing. The set will be used for activity analysis and will include all
randomized subjects with baseline and treatment data. Study staff may visit subjects outside
the clinic. Per protocol, the safety analysis sets are described below in Statistical
Methods.

Peripheral venous blood samples for pharmacokinetic (PK) and immunogenic analysis of DAS181
will be obtained on 10 subjects enrolled in each study arm.


We found this trial at
21
sites
Nashville, Tennessee
332
mi
from 43215
Nashville, TN
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Albany, New York
515
mi
from 43215
Albany, NY
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Atlanta, Georgia
436
mi
from 43215
Atlanta, GA
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Austin, Texas
1065
mi
from 43215
Austin, TX
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Boston, Massachusetts
643
mi
from 43215
Boston, MA
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Celebration, Florida
809
mi
from 43215
Celebration, FL
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Charleston, South Carolina
525
mi
from 43215
Charleston, SC
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Chevy Chase, Maryland 20815
324
mi
from 43215
Chevy Chase, MD
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Coeur D'Alene, Idaho
1748
mi
from 43215
Coeur D'Alene, ID
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Denver, Colorado
1162
mi
from 43215
Denver, CO
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Henderson, Nevada
1751
mi
from 43215
Henderson, NV
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78
mi
from 43215
Lima, OH
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Medford, Oregon
2060
mi
from 43215
Medford, OR
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Metairie, Louisiana
797
mi
from 43215
Metairie, LA
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1514
mi
from 43215
Ogden, UT
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Omaha, Nebraska
682
mi
from 43215
Omaha, NE
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Philadelphia, Pennsylvania
416
mi
from 43215
Philadelphia, PA
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Ponca City, Oklahoma
793
mi
from 43215
Ponca City, OK
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Richmond, Virginia
344
mi
from 43215
Richmond, VA
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Santa Clara, California 95051
2093
mi
from 43215
Santa Clara, CA
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Sioux Falls, South Dakota
747
mi
from 43215
Sioux Falls, SD
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