Yoon Byung-Hak, Lee Jae Hyup, Na Kyuheum, Cho Jongho, Choe Senyon
Protein Engineering Laboratory, Joint Center for Biosciences at Songdo Smart Valley, Incheon 406-840, Republic of Korea; Department of Basic Science, Hongik Univesity, 94 Wausan-ro, Mapo-Gu, Seoul 121-791, Repulic of Korea.
Department of Orthopedic Surgery, College of Medicine, Seoul National University, SMG-SNU Boramae Medical Center, Seoul 156-707, Republic of Korea.
Regul Toxicol Pharmacol. 2015 Oct;73(1):1-8. doi: 10.1016/j.yrtph.2015.06.007. Epub 2015 Jun 21.
The subchronic (28-days) toxicity of an Activin A/BMP-2 chimera (AB204) was assessed in rats. Sprague-Dawley rats received repetitive intravenous injection of AB204 in doses of 0, 0.25 and 0.5 mg/kg for two weeks and in doses of 0, 0.08, 0.16 and 0.32 mg/kg/day for four weeks. No animal was dead and no change caused by the AB204 was observed in general symptoms, weight variation, and food and water intake as well as blood test and autopsy findings. In conclusion, the no observed adverse effects level (NOAEL) of the AB204 on rats was determined to be 0.32 mg/kg/day.
在大鼠中评估了激活素A/骨形态发生蛋白-2嵌合体(AB204)的亚慢性(28天)毒性。斯普拉格-道利大鼠接受重复静脉注射AB204,剂量分别为0、0.25和0.5毫克/千克,持续两周;以及剂量分别为0、0.08、0.16和0.32毫克/千克/天,持续四周。无动物死亡,在一般症状、体重变化、食物和水摄入量以及血液检测和尸检结果方面未观察到由AB204引起的变化。总之,确定AB204对大鼠的无观察到不良反应水平(NOAEL)为0.32毫克/千克/天。