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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Percentage of Participants With Adverse Events (AEs)
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.
Time frame: Baseline to Day 100
Percentage of Participants Requiring Hospitalization for Influenza-Related Complications
Time frame: Baseline to Day 100
Duration of Hospitalization for Influenza-Related Complications
Time frame: Baseline to Day 100
Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections
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."
Time frame: Baseline to Day 100
Percentage of Participants With Complications of Influenza
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."
Time frame: Baseline to Day 100
Percentage of Participants With Influenza A Relapse/Reinfection
Time frame: Baseline to Day 100
Area Under the Concentration-Time Curve (AUC) of MHAA4549A
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).
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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
...and 70 more locations
Time frame: 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)
Maximum Serum Concentration (Cmax) of MHAA4549A
Time frame: 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)
Time to Alleviation of Symptoms of Influenza A Infection
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.
Time frame: Baseline to Day 14
Percentage of Participants With Influenza-Related Deaths
Time frame: Baseline to Day 100