Last updated on July 2017

Study of VIS410 in Subjects With Uncomplicated Influenza A


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Influenza
  • Age: Between 18 - 65 Years
  • Gender: Male or Female
  • Other:
    Male and female subjects aged ≥18 years and ˂65 years
    Women should fulfill one of the following criteria:
    Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone >40
    mIU/mL as documented in their medical history
    Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
    Women of childbearing potential participating in heterosexual sexual relations
    must be willing to use adequate contraception from screening until 60 days post
    infusion
    Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects
    who have a female partner of childbearing potential must use an effective birth
    control method when having heterosexual intercourse, from screening until 60 days post
    infusion
    Test positive for influenza A by Rapid Antigen Test performed with a commercially
    available test on an adequate nasopharyngeal specimen in accordance with the
    manufacturer's instructions
    Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms)
    of moderate to severe intensity, or presence of at least one constitutional symptom
    (myalgia [aches and pains], headache, feverishness, or fatigue) of moderate to severe
    intensity
    Onset of symptoms (time when the temperature was first measured as elevated
    [temperature of ≥100.4°F or ≥38°C], OR the time when the subject experienced at least
    one respiratory symptom or at least one constitutional symptom) no more than 72 hours
    before the start of infusion

You may not be eligible for this study if the following are true:

  • Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception
    of those used as part of the pretreatment regimen
    History of intolerance or allergic response to monoclonal antibodies and/or
    pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)
    Subject weight less than (<) 45 kg
    Subjects with clinical history that would lead to increased risk of influenza
    complications including but not limited to clinically significant cardiac disease,
    moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary
    disease, metabolic syndrome including moderate to severe diabetes or active
    tuberculosis
    History of chronic GI disease, including bleeding, ulceration, Irritable Bowel
    Syndrome, systemic mastocytosis or chronic diarrhea
    Women who are pregnant, breast-feeding, or considering becoming pregnant
    Patients with hypoxemia requiring oxygen support
    Clinical evidence of worsening of any chronic medical condition (temporally associated
    with the onset of symptoms of influenza) which, in the Investigator's opinion,
    indicates that such finding(s) could represent complications of influenza
    Presence of immunocompromised status due to chronic illness, previous organ
    transplant, or use of immunosuppressive medical therapy including systemic steroids
    Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic
    hepatitis B or hepatitis C
    Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine,
    amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to
    creening
    Enrollment in any other investigational drug or device study, any disease or vaccine
    tudy within 30 days prior to Day 1 or within 5 half-lives of the investigational
    compound, whichever is longer
    Subjects unable to take oral predose medication
    Known or suspected alcohol or drug abuse, that is, abuse of a level that would
    compromise the safety or cooperation of the subject in the opinion of the Investigator
    Subjects on chronic medications where the dose has not been stable for at least 3
    months

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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