智通财经APP讯，上海莱士(002252.SZ)公告，公司近日在国家药品监督管理局药物临床试验登记与信息公示平台公示了IIb期临床试验登记信息，试验名称为：评价SR604注射液在血友病A/B及先天性凝血因子Ⅶ缺乏症患者中的安全性、耐受性、有效性、PK/PD特征的开放、多中心Ⅰ/Ⅱ期临床试验。
据公告所示，SR604注射液拟用于血友病A/B及先天性凝血因子Ⅶ缺乏症患者出血的预防治疗。SR604通过皮下注射给药，预防治疗改善出血，目前已完成PartA剂量递增Ⅰ期试验(单次给药阶段)共6个剂量组的受试者入组、用药，分别为0.025mg/kg、0.05mg/kg、0.1mg/kg、0.2mg/kg、0.4mg/kg、0.8mg/kg;以及PartB疗效探索Ⅱa期试验(多次给药阶段)共2个剂量组：0.05mg/kg和0.1mg/kg，每2周给药一次共6个月的受试者入组。已有的安全性和初步有效性数据支持开展PartC疗效探索Ⅱb期试验(多次给药阶段)，将开展0.4mg/kg剂量组每4、6、8周给药一次共6个月的3组用药间隔试验。
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