歌礼制药(01672.HK)附属新药I期临床试验取得良好数据
歌礼制药(01672.HK)公布,旗下全资附属公司甘莱制药公布ASC41口服片剂I期临床试验的良好数据。ASC41是一种具有肝脏靶向性的前体药物,其活性代谢产物是一种甲状腺激素β受体(THR-β)的选择性激动剂。
在多剂量递增的临床研究中,经过14天每日口服一次ASC41片剂治疗後,给药组受试者的低密度脂蛋白胆固醇(LDL-C)和甘油三酯(TG)指标相对安慰剂组表现出具有临床意义和统计学显着性的降低。
在14天治疗中,ASC41在所有剂量组中无3级或以上不良事件、严重不良事件或提前停药事件发生。在14天每日口服一次ASC41片剂的研究中,从1 mg到5 mg,ASC41片剂的体内药物暴露量(药代动力学)呈线性关系。
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