歌禮製藥(01672.HK)附屬新藥I期臨床試驗取得良好數據
歌禮製藥(01672.HK)公布,旗下全資附屬公司甘萊製藥公佈ASC41口服片劑I期臨床試驗的良好數據。ASC41是一種具有肝臟靶向性的前體藥物,其活性代謝產物是一種甲狀腺激素β受體(THR-β)的選擇性激動劑。
在多劑量遞增的臨床研究中,經過14天每日口服一次ASC41片劑治療後,給藥組受試者的低密度脂蛋白膽固醇(LDL-C)和甘油三酯(TG)指標相對安慰劑組表現出具有臨床意義和統計學顯著性的降低。
在14天治療中,ASC41在所有劑量組中無3級或以上不良事件、嚴重不良事件或提前停藥事件發生。在14天每日口服一次ASC41片劑的研究中,從1 mg到5 mg,ASC41片劑的體內藥物暴露量(藥代動力學)呈線性關係。
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