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A Phase 1, Open Label, Ascending Dose Cohort Study of the Pharmacokinetics of Anti-Influenza Hyperimmune Intravenous Immunoglobulin in Healthy Subjects
The purpose of this study is to understand how much IVIG is needed to achieve a certain antibody level in the blood. We are using an IVIG preparation produced by Cangene, a Canadian company very experienced in manufacturing antibody-based medications. However, IVIG is not currently approved by the Food and Drug Administration (FDA) for treating the flu. The results of this study will be used to determine the best dose of IVIG to use in a larger study testing whether IVIG is actually useful for patients with the flu. Approximately 12 volunteers will be participating in this study. The study will last for 28 days for each volunteer. We will be testing this drug at three dosing levels, and you will know which dose of antibodies you will receive.
We will take a medical history and then perform a physical examination. We will take your vital signs (blood pressure, heart rate, respiration rate, and temperature. We will also take approximately 2 tablespoons of blood to measure levels of certain substances in your blood that can tell us if your organs are working properly. We will test for HIV-1, Hepatitis B, and Hepatitis C. If you are female of child-bearing potential, we will test to make sure you are not pregnant.
If you do not qualify for the study, we will tell you why. If you do qualify, we will call you to schedule a return visit. The return visit needs to be within 4 weeks of the screening visit.
On the day of study drug administration, we will have you come to the clinic early in the day. We will repeat some blood work. We will then administer the study medication (FLU-IVIG). This study medicine is given through a soft plastic catheter tube placed by needle into your vein (IV). This process is called an infusion. We will also place an IV in the other arm for blood draws. The infusion is given slowly at first, then increases. The entire infusion will be over approximately 2 hours. We will then keep you in the clinic for at least 2 hours after the end of the infusion. We will check your vital signs and draw a blood sample at the end of infusion and approximately 1 hour after the infusion ended.
We need you to return to the Clinical Center on Days 3, 7, 14, and 28. Each of these visits should take approximately 2 hours. On each of these days, we will draw a blood sample to make sure the study drug did not affect your body and organs. We will also test for levels of the study drug. If at any point after you get the study medicine you do not feel well, it is important that you contact the study center right away or get medical attention if you think you need it.
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Last Updated January 22, 2014
Last Reviewed January 22, 2014