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
Vancouver, British Columbia
119
mi
from 98109
Vancouver,
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6071 West Outer Drive
Detroit, Michigan 48235
1924
mi
from 98109
Detroit, MI
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
2092
mi
from 98109
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,...
2527
mi
from 98109
Tampa, FL
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
1454
mi
from 98109
Topeka, KS
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
1440
mi
from 98109
Wichita, KS
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2344
mi
from 98109
Annapolis, MD
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Athens, Alabama 35811
2038
mi
from 98109
Athens, AL
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2555 Boiling Springs Road
Boiling Springs, South Carolina 29316
2237
mi
from 98109
Boiling Springs, SC
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Butte, Montana 59701
477
mi
from 98109
Butte, MT
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Centennial, Colorado 80112
1032
mi
from 98109
Centennial, CO
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Costa Mesa, California 92626
992
mi
from 98109
Costa Mesa, CA
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Detroit, Michigan 48201
1932
mi
from 98109
Detroit, MI
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Doral, Florida 33166
2724
mi
from 98109
Doral, FL
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Edgewater, Florida 32132
2547
mi
from 98109
Edgewater, FL
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Fountain Valley, California 92708
988
mi
from 98109
Fountain Valley, CA
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1976
mi
from 98109
Franklin, TN
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Gainesville, Florida 32607
2450
mi
from 98109
Gainesville, FL
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1937
mi
from 98109
Galveston, TX
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Hazard, Kentucky 41701
2094
mi
from 98109
Hazard, KY
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2725
mi
from 98109
Hialeah, FL
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Houston, Texas 77062
1910
mi
from 98109
Houston, TX
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Knoxville, Tennessee 37920
2110
mi
from 98109
Knoxville, TN
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La Vista, Nebraska 68128
1365
mi
from 98109
La Vista, NE
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Lauderhill, Florida 33319
2710
mi
from 98109
Lauderhill, FL
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286 Westward Drive
Miami, Florida 33135
2725
mi
from 98109
Miami, FL
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Miami, Florida 33144
2727
mi
from 98109
Miami, FL
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1200 Hospital Drive
Opelousas, Louisiana 70570
1986
mi
from 98109
Opelousas, LA
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Pharr, Texas 78577
1977
mi
from 98109
Pharr, TX
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Princeton, New Jersey 08540
2383
mi
from 98109
Princeton, NJ
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Providence, Rhode Island 02908
2485
mi
from 98109
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...
2356
mi
from 98109
Raleigh, NC
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Royal Oak, Michigan 48073
1921
mi
from 98109
Royal Oak, MI
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3505 Progress Lane
Saint Cloud, Florida 34769
2564
mi
from 98109
Saint Cloud, FL
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Saint Louis, Missouri 63110
1717
mi
from 98109
Saint Louis, MO
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Smyrna, Tennessee 37167
1990
mi
from 98109
Smyrna, TN
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Trinity, Florida 34655
2505
mi
from 98109
Trinity, FL
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1433
mi
from 98109
Wichita, KS
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Worcester, Massachusetts 01605
2454
mi
from 98109
Worcester, MA
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