A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
- Registration Number
- NCT02623322
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive single-dose placebo by IV administration. MHAA4549A 3600 milligrams (mg) MHAA4549A Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration. MHAA4549A 8400 mg MHAA4549A Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Baseline to Day 100 An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Requiring Hospitalization for Influenza-Related Complications Baseline to Day 100 Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections Baseline to Day 100 Participants with antibiotic usage for secondary bacterial respiratory infections were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."
Maximum Serum Concentration (Cmax) of MHAA4549A Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) Percentage of Participants With Complications of Influenza Baseline to Day 100 Participants with complications of influenza were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."
Percentage of Participants With Influenza A Relapse/Reinfection Baseline to Day 100 Area Under the Concentration-Time Curve (AUC) of MHAA4549A Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) The AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was measured in micrograms times hours per milliliter (mcg\*h/mL).
Time to Alleviation of Symptoms of Influenza A Infection Baseline to Day 14 Time to alleviation of all 7 symptoms (i.e., nasal congestion, sore throat, cough, aches, fatigue, headaches, chills/sweats) was assessed using a rating scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe) for each symptom. The outcome was defined in two ways: time to a total symptom score of \<=1 and time to a total symptom score of \<=7. Resolution had to be maintained for 24 hours without use of symptom relief medications. For participants who were enrolled with mild symptoms, the symptom score had to be reduced by one point during the study duration.
Duration of Hospitalization for Influenza-Related Complications Baseline to Day 100 Percentage of Participants With Influenza-Related Deaths Baseline to Day 100
Trial Locations
- Locations (79)
Oceane7 Clinical Research
🇺🇸Miami, Florida, United States
North Alabama Research Center LLC
🇺🇸Athens, Alabama, United States
Lalla-Reddy Medical Corporation
🇺🇸Fountain Valley, California, United States
WCCT Global, LLC
🇺🇸Costa Mesa, California, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Integrity Clinical Research
🇺🇸Doral, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
The Community Research Of South Florida
🇺🇸Hialeah, Florida, United States
South Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Central Florida Internists
🇺🇸Saint Cloud, Florida, United States
Anne Arundel Medical Center; Anne Arundel Health System
🇺🇸Annapolis, Maryland, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Center For Medical Research LLC
🇺🇸Providence, Rhode Island, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
Clinical Research Solutions PC
🇺🇸Knoxville, Tennessee, United States
Emergency MD
🇺🇸Boiling Springs, South Carolina, United States
Centex Studies
🇺🇸Pharr, Texas, United States
inVentiv Health Clinique
🇨🇦Quebec, Canada
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Manna Research
🇨🇦Toronto, Ontario, Canada
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon-si,, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Optimal Clinical Trials
🇳🇿Auckland, New Zealand
RMC Medical Research Ltd
🇳🇿Dunedin, New Zealand
Henderson Medical Centre
🇳🇿Auckland, New Zealand
Johese Clinical Research
🇿🇦Centurion, South Africa
Vawda Z Private Practice
🇿🇦Durban, South Africa
Durban International Clinical Research Site
🇿🇦Durban, South Africa
Dr Peter John Sebastian; Dr PJ Sebastian
🇿🇦Durban, South Africa
Into Research; Life Groenkloof Hospital Medical Centre
🇿🇦Groenkloof, South Africa
Clinresco Centres (Pty) Ltd
🇿🇦Kempton Park, South Africa
Newtown Clinical Research
🇿🇦Johannesburg, South Africa
Worthwhile Clinical Trials
🇿🇦Johannesburg, South Africa
Klerksdorp /Tshepong Hospital Complex
🇿🇦Klerksdorp, South Africa
Peermed Clinical Trial Centre
🇿🇦Kempton Park, South Africa
Queenswood CTC
🇿🇦Queenswood, South Africa
I Engelbrecht Research
🇿🇦Lyttleton, South Africa
DJW Navorsing
🇿🇦Krugersdorp, South Africa
Syzygy Clinical Research; Unit 3 to 7
🇿🇦Pretoria Gauteng Province, South Africa
Wits Clinical Research
🇿🇦Soweto, South Africa
Welkom Clinical Trial Centre
🇿🇦Welkom, South Africa
Hospital San Pedro
🇪🇸Logroño, LA Rioja, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Surrey Clinical Research Centre; University of Surrey
🇬🇧Guildford, United Kingdom
Hospital de Galdakao
🇪🇸Galdacao, Vizcaya, Spain
Barts and the London NHS Trust.
🇬🇧London, United Kingdom
The James Cook University Hospital
🇬🇧Middlesborough, United Kingdom
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Acadiana Medicine Clinic
🇺🇸Opelousas, Louisiana, United States
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca, Islas Baleares, Spain
HCCA Clinical Research Solutions
🇺🇸Franklin, Tennessee, United States
Global Medical Institutes, LLC
🇺🇸Princeton, New Jersey, United States
UMASS Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Barrett Clinic, P.C.
🇺🇸La Vista, Nebraska, United States
Clinical Research Solutions, LLC
🇺🇸Smyrna, Tennessee, United States
Q and T Research
🇨🇦Gatineau, Quebec, Canada
Hospital Mutua de Terrassa; Servicio de Oncologia
🇪🇸Terrassa, Barcelona, Spain
Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of
Tauranga Hospital
🇳🇿Tauranga, New Zealand
Jongaie Research
🇿🇦Pretoria-West, South Africa
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Sinai Grace Hospital
🇺🇸Detroit, Michigan, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Advanced Research Institute, Inc.
🇺🇸Trinity, Florida, United States
Kentucky Lung Clinic
🇺🇸Hazard, Kentucky, United States
MedPharmics
🇺🇸Metairie, Louisiana, United States
Manna Research Vancouver
🇨🇦Vancouver, British Columbia, Canada