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
Chevy Chase, Maryland 20815
1124
mi
from
Chevy Chase, MD
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Albany, New York
1309
mi
from
Albany, NY
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Atlanta, Georgia
801
mi
from
Atlanta, GA
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Austin, Texas
517
mi
from
Austin, TX
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Boston, Massachusetts
1444
mi
from
Boston, MA
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Celebration, Florida
1143
mi
from
Celebration, FL
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Charleston, South Carolina
1063
mi
from
Charleston, SC
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Coeur D'Alene, Idaho
1176
mi
from
Coeur D'Alene, ID
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Denver, Colorado
409
mi
from
Denver, CO
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Henderson, Nevada
954
mi
from
Henderson, NV
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761
mi
from
Lima, OH
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Medford, Oregon
1357
mi
from
Medford, OR
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Metairie, Louisiana
693
mi
from
Metairie, LA
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Nashville, Tennessee
619
mi
from
Nashville, TN
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790
mi
from
Ogden, UT
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Omaha, Nebraska
262
mi
from
Omaha, NE
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Philadelphia, Pennsylvania
1225
mi
from
Philadelphia, PA
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Ponca City, Oklahoma
83
mi
from
Ponca City, OK
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Richmond, Virginia
1113
mi
from
Richmond, VA
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Santa Clara, California 95051
1320
mi
from
Santa Clara, CA
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Sioux Falls, South Dakota
404
mi
from
Sioux Falls, SD
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