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
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6071 West Outer Drive
Detroit, Michigan 48235
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
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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,...
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Annapolis, MD
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Athens, Alabama 35811
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2555 Boiling Springs Road
Boiling Springs, South Carolina 29316
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Butte, Montana 59701
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Centennial, Colorado 80112
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Costa Mesa, California 92626
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Detroit, Michigan 48201
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Doral, Florida 33166
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Edgewater, Florida 32132
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Fountain Valley, California 92708
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Franklin, TN
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Gainesville, Florida 32607
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Galveston, TX
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Hazard, Kentucky 41701
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Houston, Texas 77062
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Knoxville, Tennessee 37920
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La Vista, Nebraska 68128
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Lauderhill, Florida 33319
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286 Westward Drive
Miami, Florida 33135
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Miami, Florida 33144
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1200 Hospital Drive
Opelousas, Louisiana 70570
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Pharr, Texas 78577
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Princeton, New Jersey 08540
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Providence, Rhode Island 02908
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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...
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Royal Oak, Michigan 48073
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3505 Progress Lane
Saint Cloud, Florida 34769
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Saint Louis, Missouri 63110
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Smyrna, Tennessee 37167
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Trinity, Florida 34655
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Vancouver, British Columbia
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Worcester, Massachusetts 01605
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