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開拓藥業-B(09939.HK):普克魯胺在美國成功啟動COVID-19 III期臨牀試驗及患者給藥
格隆匯 04-25 19:52

格隆匯 4 月 25日丨開拓藥業-B(09939.HK)宣佈,在美國進行的用於治療輕中症男性COVID-19患者的普克魯胺III期臨牀試驗已完成首位患者入組和給藥。

該臨牀試驗是一項隨機、雙盲、安慰劑對照、全球多中心關鍵性試驗,旨在評估普克魯胺治療輕中症男性COVID-19非住院患者的療效和安全性。臨牀試驗的主要終點是28天內住院事件(包括死亡)的比例。臨牀試驗的次要終點包括但不限於28天內的死亡率、使用美國國家過敏和傳染病研究所(NIAID)8分等級量表計量的第7天、第14天及第28天臨牀評估每種臨牀狀態的受試者比例。

集團將加快臨牀試驗,並與美國FDA保持密切溝通

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