Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: VIS410 low dose; VIS410 high dose; Placebo
Intervention description: Single intravenous fixed low dose of VIS410; Single intravenous fixed high dose of VIS410; Single intravenous infusion of placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the
      safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with
      uncomplicated influenza.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged ≥18 years and ˂65 years

          -  Women should fulfill one of the following criteria:

               1. Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone >40
                  mIU/mL (milli-international units/milliliter) as documented in their medical
                  history

               2. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation

               3. 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

        Exclusion Criteria:

          -  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
             screening

          -  Enrollment in any other investigational drug or device study, any disease or vaccine
             study 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