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A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects
The primary goal of this study is to evaluate a new anti-viral drug called AVI-7100 that might have activity against the influenza virus. This drug is being studied and has not been approved by the Food and Drug Administration (FDA). This drug is given through a vein (IV), and is not like any of the drugs currently available for influenza. The drug binds to the genetic material of the virus and may keep a person who takes the drug from having a more serious case of the flu.
The purpose of this study is to learn how safe and how well tolerated this medication may be. The medication has only been given to 6 humans so far. In those people it was well tolerated (one person had a headache), but it was given at very low doses. This study will give increasingly larger doses until we reach the largest dose we have planned to test, or until the people who are receiving the drug have side effects that limit going any farther. Then it will be given to people in multiple doses. This means that people who join this study later on will be getting larger doses of the drug, and may get the drug several times, instead of only once.
We will recruit 40 subjects for the single-dose cohort, and 24 subjects for the cohort later. The investigational drug is administered by IV, and that visit requires at least a 12 hour stay. Additional visits include physical exams and blood draws. There will be about six visits required in about a one month period. Volunteers will be compensated.
Last Updated February 20, 2013
Last Reviewed February 20, 2013