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

Phase 2

Completed

Conditions: Influenza A

Interventions: Drug: Placebo
Drug: MHAA4549A

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

Inclusion Criteria

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

Exclusion Criteria

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 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
Percentage of Participants Requiring Hospitalization for Influenza-Related Complications	Baseline to Day 100

Trial Locations

Locations (79): 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
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North Alabama Research Center LLC
🇺🇸Athens, Alabama, United States