歌禮制藥-B(01672.HK):臨試申請獲批僅半月後ASC43F美國I期臨試完成首例受試者給藥
格隆匯11月18日丨歌禮制藥-B(01672.HK)發佈公吿,公司全資附屬公司甘萊的ASC43F美國I期臨牀試驗已完成首例受試者給藥。ASC43F是一種用於治療非酒精性脂肪性肝炎(NASH)的同類第一、針對甲狀腺激素β受體(THRβ)和法尼醇X受體(FXR)雙靶點的口服固定劑量複方製劑 (FDC)。該美國I期臨牀試驗是一項開放標籤、單劑量研究,旨在評估ASC43F在健康受試者中的安全性、耐受性和藥代動力學。
根據披露,ASC43F是由5 mg ASC41(甲狀腺激素β受體激動劑)和15 mg ASC42(法尼醇X受體激動劑)組成的固定劑量單片複方製劑,每日用藥一次。此前在美國和中國進行的I期臨牀研究顯示,ASC41在健康受試者和非酒精性脂肪性肝病(NAFLD)患者中具有良好的耐受性和藥代動力學特徵,並在低密度脂蛋白膽固醇(LDL-C)升高的超重和肥胖受試者(具有非酒精性脂肪性肝炎特徵的人羣)中顯着降低低密度脂蛋白膽固醇、甘油三酯(TG)和總膽固醇(TC)。
I期臨牀試驗數據顯示,ASC42安全性和耐受性良好,在15 mg每日1次為期14天的治療期間未觀察到瘙癢症狀,且低密度脂蛋白膽固醇在治療期間維持正常水平。經過15 mg每日1次為期14天的治療後,FXR靶向激活的生物標誌物成纖維細胞生長因子19 (FGF19)在給藥第14天時的增幅高達1,780%,7α-羥基-4-膽甾烯-3- 酮(C4)在給藥第14天時的降幅高達91%。動物研究表明,來源於ASC43F片的ASC42和ASC41A(ASC41的活性代謝產物)的藥代動力學參數與ASC42和ASC41單片的藥代動力學參數保持一致。
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