联邦制药(03933)：1类创新药UBT251注射液已完成在中国健康受试者的Ia期临床研究
联邦制药(03933)发布公告，公司全资附属公司联邦生物科技(珠海横琴)有限公司自主研发的 1 类创新药 UBT251 注射液已完成在中国健康受试者的 Ia 期临床。本采用随机、双盲、安慰剂对照，剂量递增的试验设计，旨在评估在健康受试者中单次皮下注射 UBT251 的安全性、耐受性、药代动力学和药效动力学。
本结果显示，单次给药后各剂量组安全性和耐受性良好，无一例受试者煺出，未发生严重不良事件，常见副反应为轻到中度的食欲减煺和胃肠道相关不良事件。1.0~4.5mg剂量范围内，UBT251暴露增加比例与剂量增加比例基本一致，呈线性药代动力学特征，各剂量组半衰期平均值为137~170h，支持一周一次注射给药。1.0~4.5mg剂量范围内，受试者体重较基线明显下降，最大降低幅度(Emax)平均值范围为-3.19~-4.80kg，明显优于安慰剂组。
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