Testing the AVI-7100 Flu Drug in Healthy Volunteers

This is an interventional treatment trial for Influenza focused on measuring Antisense, Influenza, IV Injection, RNA Based Therapeutic, RNA Interference Read More

• INCLUSION CRITERIA:

  1. Age greater than or equal to 18 years and less than or equal to 60 years
  2. Body mass index (BMI) of 19-32 kg/m(2)
  3. Estimated glomerular filtration rate greater than or equal to 90 mL/min at screening, calculated using the MDRD formula
  4. Subjects must agree to:
• Not take any prescription or OTC medications with the exception of Tylenol, vitamins, seasonal allergy medications, and/or contraceptive medications for a period 7 days prior and during study drug administration.

• Not consume any alcohol for a period 2 days prior to and during study drug administration.

  5. One of the following in order to avoid pregnancy:

• Females who are able to become pregnant (i.e., are not postmenopausal)
• have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception.
• From the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug. At least one of the methods of contraception should be a barrier method.
• Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug.

EXCLUSION CRITERIA:

1. 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.
2. History of cardiovascular disease or unexplained syncope
3. Women who are breast-feeding.
4. Positive urine or serum pregnancy test.

5. 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.

6. 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.

7. 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.

8. Abnormal urinalysis

   -defined as any clinically significant baseline Grade 1 or greater toxicity

   --evaluating only protein, and RBCs.

9. Urine-albumin-to-creatinine ratio (UACR) >30 mg/g.
10. Positive serology for Hepatitis B surface antigen.
11. Positive serology for Hepatitis C.
12. Positive serology for HIV-1.
13. Positive urine drug screen.
14. 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)
15. Donation of blood or blood products within 30 days or plasma within 2 weeks prior to study drug administration (i.e., Day 0)
16. Receipt of blood products within 2 months prior to study drug administration (i.e., Day 0)
17. Receipt of any vaccination within 30 days prior to study drug administration (i.e., Day 0)
18. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject s ability to complete and/or participate in this clinical study.