A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:1/10/2019
Start Date:October 12, 2016
End Date:November 13, 2017

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, Administered as Monotherapy for the Treatment of Acute Uncomplicated Seasonal Influenza A Infection in Otherwise Healthy Adults

This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in
otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety
and tolerability, efficacy, and pharmacokinetics of MHAA4549A.


Inclusion Criteria:

- Otherwise healthy participants

- Positive test for influenza A infection

- No more than 72 hours elapsed between onset of influenza-like illness and start of
study drug

- Presence of at least one moderate or severe constitutional symptom such as headache,
myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe
respiratory symptom such as cough, sore throat, or rhinorrhea

- For women of childbearing potential: negative pregnancy test and agreement to use
acceptable contraceptive methods for at least 120 days after study drug administration

- For men: agreement to use acceptable contraceptive methods for at least 30 days after
study drug administration

Exclusion Criteria:

- Creatinine clearance less than or equal to (
- Any significant medical conditions or laboratory abnormalities

- Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or
pneumonia or active bacterial infection

- Use of antiviral therapy in the period from onset of influenza-like illness and prior
to enrollment

- Pregnancy at Screening or is currently pregnant or breastfeeding

- Investigational therapy within 30 days or 5 half-lives prior to start of study drug,
whichever is greater

- Prior anti-influenza monoclonal antibody use

- Receipt of a nasal influenza A vaccine within 14 days prior to Screening

- Positive test for influenza B or influenza A+B within 2 weeks prior to study drug

- History of significant tobacco use or drug/alcohol abuse

- Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening

- Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive
medications

- History of any chronic respiratory condition

- Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count 200 cells per milliliter (cells/mL) in the past 12 months

- Serious infection requiring oral or IV antibiotics within 14 days prior to Screening
We found this trial at
39
sites
1314
mi
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Hialeah, FL
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6071 West Outer Drive
Detroit, Michigan 48235
836
mi
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Detroit, MI
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
690
mi
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Metairie, LA
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
1117
mi
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Tampa, FL
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
146
mi
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Topeka, KS
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
32
mi
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Wichita, KS
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1155
mi
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Annapolis, MD
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Athens, Alabama 35811
661
mi
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Athens, AL
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2555 Boiling Springs Road
Boiling Springs, South Carolina 29316
900
mi
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Boiling Springs, SC
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Butte, Montana 59701
943
mi
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Butte, MT
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Centennial, Colorado 80112
400
mi
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Centennial, CO
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Costa Mesa, California 92626
1158
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Costa Mesa, CA
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Detroit, Michigan 48201
841
mi
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Detroit, MI
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Doral, Florida 33166
1313
mi
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Doral, FL
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Edgewater, Florida 32132
1145
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Edgewater, FL
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Fountain Valley, California 92708
1160
mi
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Fountain Valley, CA
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618
mi
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Franklin, TN
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Gainesville, Florida 32607
1046
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Gainesville, FL
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609
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Galveston, TX
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Hazard, Kentucky 41701
801
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Hazard, KY
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Houston, Texas 77062
586
mi
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Houston, TX
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Knoxville, Tennessee 37920
777
mi
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Knoxville, TN
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La Vista, Nebraska 68128
255
mi
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La Vista, NE
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Lauderhill, Florida 33319
1300
mi
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Lauderhill, FL
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286 Westward Drive
Miami, Florida 33135
1315
mi
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Miami, FL
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Miami, Florida 33144
1316
mi
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Miami, FL
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1200 Hospital Drive
Opelousas, Louisiana 70570
596
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Opelousas, LA
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Pharr, Texas 78577
798
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Pharr, TX
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Princeton, New Jersey 08540
1252
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Princeton, NJ
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Providence, Rhode Island 02908
1424
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Providence, RI
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
1064
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Raleigh, NC
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Royal Oak, Michigan 48073
838
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Royal Oak, MI
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3505 Progress Lane
Saint Cloud, Florida 34769
1158
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Saint Cloud, FL
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Saint Louis, Missouri 63110
414
mi
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Saint Louis, MO
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Smyrna, Tennessee 37167
636
mi
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Smyrna, TN
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Trinity, Florida 34655
1095
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Trinity, FL
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Vancouver, British Columbia
1486
mi
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Vancouver,
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25
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Wichita, KS
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Worcester, Massachusetts 01605
1406
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Worcester, MA
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