Pharmacokinetic Study of AVI-4126 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration
- Adult males 18 years to 64 years of age;
- Good general health (as evidenced by no chronic conditions, normal physical exam,
vital signs within normal limits; laboratory evaluations within normal range)
- Signed and dated written informed consent form; and
- Willing to participate in all study activities and all requirements, including
effective contraception (viz., a double-barrier method) during the 7-day study
- Hematology, serum chemistry (exclusive of electrolytes), and urinalysis laboratory
test values >2 times upper limits of normal or anemia (hemoglobulin <11 g/dL),
leukopenia (total white blood count <3,000/µL or total neutrophils <1,500/ µL) or
thrombocytopenia (platelets <100,000/µL). Electrolytes and coagulation values
exceeding normal ranges are to be excluded.
- Body Mass Index (BMI) >35.
- Calculated creatinine clearance (by the Cockroft and Gault Formula) <70 mL/min, based
on age and gender.
- Positive HIV-1 or HIV-2 serology.
- Positive HCV serology and/or positive plasma HCV-RNA status.
- Positive HBsAg or HBcAb status.
- Solid or hematopoetic organ transplant recipient.
- Active illness or recent illness within 30 days of the first dose of study drug.
- History of any of the following: brain injury, neoplasm, chronic or migraine
headaches, cancer, meningitis or hydrocephalus.
- Usage of any prescribed, over-the-counter or illicit drug(s) within 30 days of study
drug administration. Use of herbal remedies and/or supplements at the discretion of
- Unwilling to practice effective contraception during the study period.
- Participation in any clinical interventional trial within the previous 6 months.
- Positive drug urine screen.