Testing the AVI-7100 Flu Drug in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Influenza
In brief
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.
Key facts
- Study ID
- NCT01747148
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 66
- Starts
- 2012-12-08
- Expected to finish
- 2016-06-29
- Last updated by the study team
- 2017-12-26
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Any chronic medical problem that requires daily oral medications (except Tylenol, oral contraceptives, vitamins, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a phase I drug.
- History of cardiovascular disease or unexplained syncope
- Women who are breast-feeding.
- Positive urine or serum pregnancy test.
- Abnormal ECG
- defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table.
- -evaluating PR interval, QTc interval and rhythm.
- Abnormal chemistry panel
- defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
- -evaluating only sodium [Na], potassium [K], serum bicarbonate [total CO2], creatinine, glucose,albumin, ALT, AST, ALKP, GGT, total bilirubin, LDH, and estimated GFR by the MDRD equation.
- Abnormal complete blood count (CBC)
- defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
- - evaluating only the WBC (to include absolute neutrophil and lymphocyte counts), hemoglobin, hematocrit, and platelets.
- Abnormal urinalysis
- defined as any clinically significant baseline Grade 1 or greater toxicity
- -evaluating only protein, and RBCs.
- Urine-albumin-to-creatinine ratio (UACR) >30 mg/g.
- Positive serology for Hepatitis B surface antigen.
- Positive serology for Hepatitis C.
- Positive serology for HIV-1.
- Positive urine drug screen.
- Participation in a study with receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study drug administration (i.e., Day 0)
- Donation of blood or blood products within 30 days or plasma within 2 weeks prior to study drug administration (i.e., Day 0)
- Receipt of blood products within 2 months prior to study drug administration (i.e., Day 0)
- Receipt of any vaccination within 30 days prior to study drug administration (i.e., Day 0)
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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