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

Completed · Phase 2 · Has a placebo group

Conditions studied: Influenza A

In brief

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.

Key facts

Study ID

NCT02623322

Run by

Genentech, Inc.

People needed

124

Starts

2016-10-12

Expected to finish

2017-11-13

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Creatinine clearance less than or equal to (</=) 80 milliliters per minute (mL/min)
• 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

Where it is running

• 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
• North Alabama Research Center LLC — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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