A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
NCT ID: NCT02623322
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2016-10-12
2017-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MHAA4549A 3600 milligrams (mg)
Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration.
MHAA4549A
MHAA4549A will be administered as a single dose by IV administration.
MHAA4549A 8400 mg
Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration.
MHAA4549A
MHAA4549A will be administered as a single dose by IV administration.
Placebo
Participants will receive single-dose placebo by IV administration.
Placebo
Placebo will be administered as a single dose by IV administration.
Interventions
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MHAA4549A
MHAA4549A will be administered as a single dose by IV administration.
Placebo
Placebo will be administered as a single dose by IV administration.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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North Alabama Research Center LLC
Athens, Alabama, United States
WCCT Global, LLC
Costa Mesa, California, United States
Lalla-Reddy Medical Corporation
Fountain Valley, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Integrity Clinical Research
Doral, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
The Community Research Of South Florida
Hialeah, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
South Florida Research Center, Inc.
Miami, Florida, United States
Oceane7 Clinical Research
Miami, Florida, United States
Central Florida Internists
Saint Cloud, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Advanced Research Institute, Inc.
Trinity, Florida, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Professional Research Network of Kansas
Wichita, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Kentucky Lung Clinic
Hazard, Kentucky, United States
MedPharmics
Metairie, Louisiana, United States
Acadiana Medicine Clinic
Opelousas, Louisiana, United States
Anne Arundel Medical Center; Anne Arundel Health System
Annapolis, Maryland, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Detroit Medical Center
Detroit, Michigan, United States
Sinai Grace Hospital
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Mercury Street Medical Group
Butte, Montana, United States
Barrett Clinic, P.C.
La Vista, Nebraska, United States
Global Medical Institutes, LLC
Princeton, New Jersey, United States
Wake Research Associates
Raleigh, North Carolina, United States
Center For Medical Research LLC
Providence, Rhode Island, United States
Emergency MD
Boiling Springs, South Carolina, United States
HCCA Clinical Research Solutions
Franklin, Tennessee, United States
Clinical Research Solutions PC
Knoxville, Tennessee, United States
Clinical Research Solutions, LLC
Smyrna, Tennessee, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Centex Studies
Houston, Texas, United States
Centex Studies
Pharr, Texas, United States
Manna Research Vancouver
Vancouver, British Columbia, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Manna Research
Toronto, Ontario, Canada
Q and T Research
Gatineau, Quebec, Canada
inVentiv Health Clinique
Québec, , Canada
Henderson Medical Centre
Auckland, , New Zealand
Optimal Clinical Trials
Auckland, , New Zealand
RMC Medical Research Ltd
Dunedin, , New Zealand
Tauranga Hospital
Tauranga, , New Zealand
Johese Clinical Research
Centurion, , South Africa
Durban International Clinical Research Site
Durban, , South Africa
Vawda Z Private Practice
Durban, , South Africa
Dr Peter John Sebastian; Dr PJ Sebastian
Durban, , South Africa
Into Research; Life Groenkloof Hospital Medical Centre
Groenkloof, , South Africa
Worthwhile Clinical Trials
Johannesburg, , South Africa
Newtown Clinical Research
Johannesburg, , South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, , South Africa
Peermed Clinical Trial Centre
Kempton Park, , South Africa
Klerksdorp /Tshepong Hospital Complex
Klerksdorp, , South Africa
DJW Navorsing
Krugersdorp, , South Africa
I Engelbrecht Research
Lyttleton, , South Africa
Syzygy Clinical Research; Unit 3 to 7
Pretoria Gauteng Province, , South Africa
Jongaie Research
Pretoria West, , South Africa
Queenswood CTC
Queenswood, , South Africa
Wits Clinical Research
Soweto, , South Africa
Welkom Clinical Trial Centre
Welkom, , South Africa
Hallym University Sacred Heart Hospital
Anyang-si, , South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Mutua de Terrassa; Servicio de Oncologia
Terrassa, Barcelona, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital de Galdakao
Galdacao, Vizcaya, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Surrey Clinical Research Centre; University of Surrey
Guildford, , United Kingdom
Barts and the London NHS Trust.
London, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-000425-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GV29893
Identifier Type: -
Identifier Source: org_study_id
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