Influenza Clinical Trial
Official title:
A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AVI-7100 in Healthy Subjects
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.
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.
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