歌禮制藥-B(01672.HK):甘萊完全自主研發非酒精性脂肪性肝炎同類第一雙靶點固定劑量複方製劑ASC43F完成美國I期臨牀試驗
格隆匯1月4日丨歌禮制藥-B(01672.HK)發佈公吿,公司全資附屬公司甘萊製藥有限公司完成其在研管線藥物ASC43F美國I期臨牀試驗。ASC43F是公司完全自主研發的雙靶點固定劑量複方製劑(FDC),用於治療非酒精性脂肪性肝炎(NASH)。
ASC43F是由5mg甲狀腺激素β受體(THRβ)激動劑ASC41和15mg法尼醇X受體(FXR)激動劑ASC42組成的固定劑量單片複方製劑,每日用藥一次。該美國I期臨牀試驗(臨牀試驗編號:NCT05118516)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。結果顯示,ASC43F具有良好的安全性和耐受性,未出現具有臨牀意義的不良事件。來源於ASC43F片的ASC41和ASC42的藥代動力學參數與ASC41和ASC42單藥治療的藥代動力學參數具有一致性。
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