HMS-01的遗传毒性评价

Genotoxicity evaluation of HMS-01

目的检测HMS-01的遗传毒性,并对其进行临床前安全评价研究,为后续该药物进入临床试验提供支持。方法采用鼠伤寒沙门氏菌进行细菌回复突变试验(Ames试验)评价HMS-01的遗传毒性。结果HMS-01在20.6、61.7、185.2、555.6、1666.7、5000μg/皿的6个剂量下,无论有无代谢活化条件,对鼠伤寒沙门氏菌均无致突变性。结论在本实验剂量范围内,HMS-01未见致突变性。

Objective To provide a toxicological basis for HMS-01 in future clinical trials,through genotoxicity testing of safety evaluation.Methods The genotoxicity of HMS-01 was evaluated by Bacterial Reverse Mutation Assay(Ames test)with Salmonella typhimurium.Results HMS-01 was non-mutagenic against Salmonella typhimurium at six doses of 20.6,61.7,185.2,555.6,1666.7,and 5000μg/dish with(or without)a metabolic activation system.Conclusion HMS-01 was not found to be mutagenic in the dose range of this experiment.