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

  • Influenza
Trial Status:

Completed

This trial runs in
Countries
  • Canada
  • New Zealand
  • South Africa
  • South Korea
  • Spain
  • United Kingdom
  • United States
Trial Identifier:

NCT02623322 2016-000425-40 GV29893

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT02623322 , GV29893 , 2016-000425-40 Trial Identifier
      MHAA4549A, Placebo Treatments
      Influenza A Condition
      Official 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

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 65 Years Age
      No Healthy Volunteers
      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

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