伊克泽珠单抗
单克隆抗体
免疫系统
免疫学
功能(生物学)
白细胞介素
生物
抗体
医学
细胞因子
细胞生物学
银屑病
银屑病性关节炎
塞库金单抗
作者
David O. Clarke,Kim G. Hilbish,David G. Waters,Deanna Newcomb,Gary J. Chellman
标识
DOI:10.1016/j.reprotox.2015.10.008
摘要
The reproductive and developmental toxicity of ixekizumab, a selective inhibitor of interleukin-17A (IL-17A), was assessed in the following studies in cynomolgus monkeys: fertility (3-month dosing), embryo-fetal development (EFD; dosing from gestation day (GD) 20 through 139), and pre-postnatal development (PPND; dosing from GD 20 through parturition). Because IL-17A has functional roles in innate and humoral immunity, immune system modulation was evaluated in the EFD and PPND studies; immunological evaluations in infants comprised peripheral blood immunophenotyping, Natural Killer cell cytolytic activity, and T-cell-dependent antibody (IgG and IgM) primary and secondary responses to antigen challenge. Ixekizumab exposure was sustained during the dosing periods in most adult monkeys. Fetal exposure at Cesarean section (GD 140–142; EFD study) was 18–25% of maternal exposure and ixekizumab was present in infants for up to 29 weeks postpartum. There were no adverse effects attributed to ixekizumab in any study. Importantly, immune system development and maturation were unaffected.
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