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艾迪藥業(688488.SH):烏司他丁新適應症I期臨牀試驗首例受試者成功入組
格隆匯 07-18 15:59

格隆匯7月18日丨艾迪藥業(688488.SH)公佈,公司在研抗炎新藥烏司他丁(研發代碼:AD105 (烏司他丁新適應症),“AD105”)正在開展臨牀研究,AD105I臨牀試驗首例受試者於2021716日成功入組給藥。

烏司他丁是由143個氨基酸組成的糖蛋白,為廣譜絲氨酸蛋白酶抑制劑。目國內已上市的烏司他丁製劑獲批准的適應症為:急性胰腺炎、慢性複發性胰腺炎、急性循環衰竭的搶救輔助用藥。由於烏司他丁具有明確的抑制機體創傷引發過度炎症反應的作用機理,其製劑在臨牀實際應用方面更加廣泛,包括肺損傷、膿毒症和肝切除圍手術期等

AD105I期臨牀試驗在首都醫科大學附屬北京安貞醫院開展,旨在評估注射烏司他丁在中國健康成人中的單中心、隨機、雙盲、安慰劑對照、單次及多次劑量遞增的安全性及耐受性。2021716日,AD105I期臨牀試驗首例受試順利完成入組

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