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中關村(000931.SZ):知母皂苷BII膠囊I期臨牀試驗在清遠市人民醫院啟動
格隆匯 06-03 17:37

格隆匯6月3日丨中關村(000931.SZ)公佈,近日,華素製藥與軍科院放射與輻射醫學研究所合作開發的用於治療血管性痴呆的中藥1類新藥知母皂苷BII膠囊I期單次給藥的臨牀試驗信息在國家藥品監督管理局藥物臨牀試驗登記與信息公示平台公示。I期單次給藥的臨牀研究已經進行受試者篩選,並已開展第1劑量組的給藥觀察。

知母皂苷BII膠囊是華素製藥與軍科院放射與輻射醫學研究所聯合研製的中1類新藥,2018531日獲得《藥物臨牀試驗批件》(詳見2018627日,公吿編號:2018-050)。知母皂苷BII口服可顯著改善多種擬痴呆模型動物的學習記憶功能,其活性在某些方面優於臨牀一線治療藥物未來有望成為療效肯定、安全性好、具有我國自主知識產權的新型抗血管性痴呆藥物。

知母皂苷BII膠囊I期臨牀試驗在廣東省清遠市人民醫院啟動,目的是初步評價知母皂苷BII膠囊在健康受試者中單次遞增給藥的安全性和耐受性以及初步的藥代動力學特徵。

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