毒性
妊娠期
发育毒性
怀孕
加药
畸形学
生理学
生物
抗体
神经生长因子
单克隆抗体
不利影响
胎儿
医学
内科学
免疫学
受体
遗传学
作者
Christopher J. Bowman,Mark Evans,Thomas Cummings,Satoru Oneda,Mark T. Butt,Susan Hurst,Jessica-lyn Gremminger,David L. Shelton,Cris Kamperschroer,Mark Zorbas
标识
DOI:10.1016/j.reprotox.2014.10.004
摘要
Two intravenous studies with tanezumab, an anti-nerve growth factor monoclonal antibody, were conducted in pregnant cynomolgus monkeys to assess potential effects on pregnancy and pre- and postnatal development. Study 1 evaluated infants up to 12 months of age following weekly maternal dosing (0, 0.5, 4 or 30 mg/kg; 18 per group) from gestation day (GD) 20 through parturition. Study 2 evaluated infants 2 months postnatally following weekly maternal dosing (0, 0.5 or 30 mg/kg; 20-21 per group) from GD 20 through 48. In the absence of maternal toxicity, tanezumab increased stillbirth and post-birth infant mortality/morbidity, decreased infant growth and resulted in microscopic changes in the peripheral sympathetic and sensory nervous system of the infants at all doses. Decreased primary antibody responses and increased incidences in skin changes in infants were also observed. The no-observed-adverse-effect-level for maternal toxicity was 30 mg/kg and <0.5 mg/kg for developmental toxicity.
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