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2016 ; 8
(5
): 854-60
Nephropedia Template TP
gab.com Text
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Twit Text #
English Wikipedia
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
PMID27030142
show 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.