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歌禮制藥-B(01672.HK):小分子口服GLP-1R激動劑ASC30美國Ia期單劑量遞增研究取得積極成果
格隆匯 01-21 18:48

格隆匯1月21日丨歌禮制藥-B(01672.HK)公吿,在肥胖症患者中進行的單劑量遞增(SAD)研究中,ASC30口服片顯示出與劑量成比例的(dose-proportional)藥代動力學(PK)特徵,半衰期(t1/2)長達60小時,支持每日一次或更低頻率的口服給藥。

ASC30口服片整體安全性和耐受性良好。所有不良事件(AE)均為輕度(1級)或中度(2級),大部分AE與胃腸道(GI)相關。無3級或以上AE,也無嚴重不良事件(SAE)。丙氨酸氨基轉移酶(ALT)、天冬氨酸氨基轉移酶(AST)和其它肝酶均在正常範圍內。

ASC30口服片在室温下穩定。ASC30片在動物模型中的相對口服生物利用度達99%。ASC30新片劑在動物模型中的數據支持更低頻率的口服給藥,或可達一週一次。ASC30口服片每日一次治療肥胖症患者的美國Ib期多劑量遞增(MAD)研究的減重、安全性和PK等頂線結果預計於2025年3月底公佈。

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