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Author:
Wolfe, Erika J.   Cavacini, Lisa A.   Samore, Matthew H.   Posner, Marshall R.   Kozial, Carolyn   Spino, Cathie   Trapnell, Carol Braun   Ketter, Nzeera   Hammer, Scott   Gambertoglio, John G.  


Journal:
Clinical Pharmacology & Therapeutics


Issue Date:
1996


Abstract(summary):

F105 is a human monoclonal antibody that binds to the CD4 binding site of human immunodeficiency virus type 1 gp120 and neutralizes clinical and laboratory isolates of the human immunodeficiency virus, This phase I study investigated the disposition of the antibody in humans. F105 was administered over a 60-minute period at two dose levels, 100 and 500 mg/m(2). Blood samples were obtained for up to 56 days, The clearance of the antibody was 0.33 ml/min with a corresponding half-life of approximately 13 days, Peak concentrations achieved at the higher dose level were 216.19 +/- 9.62 mu g/ml. The disposition of the drug mas linear for the doses studied, Simulations were performed to design future studies aimed at investigating the efficacy of the antibody, This study concluded that F105 can be administered as a bolus dose every 21 days.


Page:
662-667


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