MHAA4549A
DrugMHAA4549A will be administered as a single dose by IV administration.
NCT Number: NCT02623322
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Manna Research Vancouver, Vancouver, British Columbia, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MHAA4549A will be administered as a single dose by IV administration.
Placebo will be administered as a single dose by IV administration.
Time frame: 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.
Time frame: Baseline to Day 100
Time frame: Baseline to Day 100
Time frame: 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."
Time frame: 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."
Time frame: Baseline to Day 100
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)
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 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 frame: 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.
Time frame: Baseline to Day 100
Genentech, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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