Testing the AVI-7100 Flu Drug in Healthy Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      - Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes
      only a mild illness, but some people can become seriously ill or even die from it. Currently,
      some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms
      end about a day sooner. More treatment choices for the flu are needed, especially for those
      who become seriously ill. Researchers want to test a new drug, AVI-7100, that might keep a
      person who takes it from having a more serious case of the flu.

      Objectives:

      - To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug.

      Eligibility:

      - Healthy volunteers of normal weight between 18 and 60 years of age.

      Design:

        -  Participants will be screened with a physical exam and medical history. Blood and urine
           samples will be collected. A heart function test will also be performed.

        -  Participants will have either AVI-7100 or a placebo infusion. They will not know which
           infusion they have. . Participants will stay at the clinical center for a total of 8
           hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after the
           end of the infusion

        -  Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood and
           urine samples will be collected. A heart function test will also be performed.

        -  There will be a second part of the study that is separate from the first one. Additional
           people will receive either AVI-7100 or placebo to test their reactions to a specific
           dose.
    

Detailed description: 
      Despite currently available antivirals, influenza causes significant morbidity and mortality
      (estimated 36,000 deaths each year in the United States alone). More agents are needed in the
      armamentarium of anti-influenza medications including novel mechanisms of action and
      parenteral agents.

      This study will evaluate the safety of a novel RNA based therapeutic AVI-7100. Beginning with
      a low single-dose, subjects are randomized to receive either AVI-7100 or placebo and
      evaluated on Study Days 0, 1, 2, 4, 10, 28. The safety and tolerability is evaluated using
      symptoms, clinical laboratory tests, ECG, and pharmacokinetics. Utilizing a series of
      stopping rules and a medical monitor, the dose will be escalated as safety and tolerability
      are established. Once the maximum tolerated dose (MTD) is established in the first part of
      this study (either limited by adverse effects or up to maximum anticipated dose), the safety
      and tolerability of multi-dose administration will begin (replicating anticipated clinical
      use). Subjects again are randomized to either AVI-7100 or placebo daily for 5 days, and
      evaluated on Study Days 0, 1, 2, 3, 4, 5, 6, 8, 14, and 32. The dose used in the multi-dose
      cohorts will also be escalated as safety and tolerability are established.
    

Intervention name(s): AVI-7100 versus placebo
Intervention type(s): Drug
Intervention description(s): dose-escalating AVI-7100 versus placebo
Intervention MeSH terms: Radavirsen
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Antisense; Influenza; IV Injection; RNA Based Therapeutic; RNA Interference