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Completed

NCT Number: NCT02623322

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

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Manna Research Vancouver, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MHAA4549A

Drug

MHAA4549A will be administered as a single dose by IV administration.

Placebo

Drug

Placebo will be administered as a single dose by IV administration.

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    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.

Secondary outcomes

  1. Percentage of Participants Requiring Hospitalization for Influenza-Related Complications

    Time frame: Baseline to Day 100

  2. Duration of Hospitalization for Influenza-Related Complications

    Time frame: Baseline to Day 100

  3. Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections

    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."

  4. Percentage of Participants With Complications of Influenza

    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."

  5. Percentage of Participants With Influenza A Relapse/Reinfection

    Time frame: Baseline to Day 100

  6. Area Under the Concentration-Time Curve (AUC) 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)

    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).

  7. 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)

  8. Time to Alleviation of Symptoms of Influenza A Infection

    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.

  9. Percentage of Participants With Influenza-Related Deaths

    Time frame: Baseline to Day 100

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 7, 2015
Registry last updated
Jan 8, 2019

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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