舒泰神(300204.SZ)披露BDB-001注射液臨牀試驗相關進展
格隆匯 1 月 18日丨舒泰神(300204.SZ)公佈,近日,公司及全資子公司北京德豐瑞生物技術有限公司(“德豐瑞”)研發的BDB-001注射液完成在新型冠狀病毒(2019-nCoV)感染患者中的安全性、耐受性、藥代動力學和藥效學Ib期臨牀研究和在健康受試者中單中心、隨機、雙盲、安慰劑對照的多劑量、單次、多次給藥的耐受性、藥代動力學Ic期臨牀試驗的臨牀研究報吿。
公司研發的BDB-001注射液於2020年02月07日獲得國家藥品監督管理局簽發的批件號為2020L00003的《藥物臨牀試驗批件》,批准BDB-001注射液進行臨牀試驗。
本品的Ib期臨牀試驗是BDB-001注射液在新型冠狀病毒(2019-nCoV)感染患者中的安全性、耐受性、藥代動力學和藥效學臨牀研究。本試驗共計入組18例受試者,研究結果表明在試驗劑量範圍內,BDB-001注射液多次給藥具有良好的安全性和耐受性。
本品的Ic期臨牀試驗旨在評價BDB-001注射液在健康受試者中單次、多次給藥的耐受性、藥代動力學特徵。本試驗共計入組32例受試者,研究結果表明在試驗劑量範圍內,BDB-001注射液單次給藥和多次給藥具有良好安全性和耐受性。BDB-001注射液單次給藥和多次給藥可以抑制健康人體內C5a水平,並且均未產生免疫原性。
截至2020年12月16日,公司及全資子公司德豐瑞在西班牙、印度和印度尼西亞開展BDB-001注射液治療進展期重型COVID-19的國際多中心、開放、隨機平行對照的II/III期臨牀試驗,入組超過70例受試者。
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