科笛集團(02487.HK)治療雄激素性脫髮產品I期臨床試驗達主要終點
科笛集團(02487.HK)公布,治療雄激素性脫髮產品CU-40101(外用小分子甲狀腺激素受體激動劑搽劑)在中國進行的I期臨床試驗達到主要終點。CU-40101的I期臨床試驗是一項隨機、雙盲、安慰劑對照和劑量遞增的試驗,以評估CU-40101對中國成年男性雄激素性脫髮患者的安全性、耐受性和藥代動力學(PK)特徵。
該臨床試驗結果顯示出CU-40101良好的安全性,在單劑和多劑給藥後均無受試者出現局部耐受性問題,達到主要終點指標。安全性方面,均未發生嚴重不良事件(SAE)、常見不良事件評價標準(CTCAE)等級大於或等於3級的治療期間發生的不良事件(TEAE)、死亡或重要不良事件。另外,均未報告甲狀腺功能和甲狀腺超聲異常有臨床意義的結果,進一步顯示了CU-40101良好的安全性。耐受性方面,無受試者發生局部皮膚耐受評估的相關不良事件(AE),顯示CU-40101受試者對給藥部位局部耐受性良好。
另外,藥代動力學研究顯示,大部分受試者均未檢測到藥物濃度,顯示藥物在皮膚給藥後系統的暴露量極低。
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