開拓藥業(09939.HK)在美國完成福瑞他恩(KX-826)Ib期臨牀試驗
格隆匯 8 月 4日丨開拓藥業-B(09939.HK)發佈公告,2020年8月3日,集團已在美國完成福瑞他恩(KX-826)Ib期臨牀試驗。福瑞他恩(KX-826)是集團開發作治療雄激素性脱髮用途的潛在同類首創小分子AR拮抗劑,並正在中國及美國持續進行臨牀試驗。
在美國的福瑞他恩(KX-826)Ib期臨牀試驗是對雄激素性脱髮健康男性受試者進行隨機、雙盲、安慰劑對照、平行組、劑量遞增的研究,以評估福瑞他恩(KX-826)於局部多次遞增劑量給藥後的安全性、耐受性及藥代動力學。就總計四個劑量組別合共招募了40名健康男性脱髮健康受試者接受評估,其中32名受試者隨機接受活性藥物,8名受試者則以雙盲方式隨機接受安慰劑(每個劑量組別10名受試者,其中2名受試者隨機接受安慰劑)。正在評估的局部使用福瑞他恩(KX-826)的劑量水平為2.5毫克、5毫克、10毫克及20毫克。
該等Ib期臨牀試驗進展順利及穩定,並未因目前的美國COVID-19疫情而受到重大影響。集團正分析及評估在美國的福瑞他恩(KX-826)Ib期臨牀試驗收集的數據,並預期將於2020年第四季確定臨牀研究報告(CSR)及發佈數據。
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