Testing the AVI-7100 Flu Drug in Healthy Volunteers
Status:
Completed
Trial end date:
2016-06-29
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)