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10.1080/19420862.2016.1168956

http://scihub22266oqcxt.onion/10.1080/19420862.2016.1168956
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C4968100!4968100!27030142
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suck abstract from ncbi


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pmid27030142      MAbs 2016 ; 8 (5): 854-60
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  • Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study #MMPMID27030142
  • Curtin F; Vidal V; Bernard C; Kromminga A; Lang AB; Porchet H
  • MAbs 2016[Jul]; 8 (5): 854-60 PMID27030142show ga
  • GNbAC1 is a humanized IgG4 monoclonal antibody antagonist of Mulitple Sclerosis Retrovirus Envelope (MSRV-Env), a protein that could play a critical role in multiple sclerosis. This randomized placebo-controlled dose-escalation study evaluated the safety and pharmacokinetics of GNbAC1 in 21 healthy volunteers after single intravenous infusion at doses of 6, 18 and 36 mg/kg. Lumbar punctures were performed at days 2, 15 or 29 to measure GNbAC1 concentrations in cerebrospinal fluid (CSF). GNbAC1 was well tolerated. Serum data show a dose-linear pharmacokinetics. A mean CSF/serum ratio of 0.12% was observed at Day 2, increasing to 0.39% at Day 15 and 0.42% at Day 29. Linear regression analysis shows a relationship between GNbAC1 CSF/serum ratio and albumin CSF/serum ratio and a relationship at the limit of statistical significance with the timing of CSF sampling.
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