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信立泰(002294.SZ):重組全人源抗PCSK9單克隆抗體注射液Ib期臨牀試驗研究已經完成揭盲並取得初步統計分析結果
格隆匯 12-16 17:55

格隆匯12月16日丨信立泰(002294.SZ)公佈,近日,公司及子公司信立泰(成都)生物技術有限公司、信立泰(蘇州)藥業有限公司自主研發的“重組全人源抗PCSK9單克隆抗體注射液”(項目代碼:SAL003)Ib 期臨牀試驗研究已經完成揭盲並取得初步的統計分析結果。SAL003擬用於高膽固醇血癥和混合型高脂血症的治療。

結果顯示:與陽性對照藥物依洛尤單抗420mg劑量組(Q4W)及安慰劑組比較,SAL003各劑量組多次給藥後表現出良好的安全性和耐受性;且SAL003 140mg(Q4W)劑量組和420mg(Q8W)劑量組在穩定服用至少4周他汀降脂治療的高膽固醇血癥和混合型高脂血症患者中,表現出降低血清低密度脂蛋白膽固醇(low-density lipoprotein cholesterol,LDL-C)及改善其他血脂指標的藥效學趨勢,後續將繼續按照臨牀試驗方案開展臨牀工作。

該I期臨牀研究旨在評價不同給藥方案的SAL003聯合阿託伐他汀多次皮下注射的安全性、耐受性和藥代動力學特徵。試驗由中國藥理學會藥物臨牀試驗專委會候任主任委員、中南大學湘雅三醫院陽國平教授,及中國高血壓聯盟理事、中南大學湘雅三醫院黃志軍教授擔任Leading PI(主要研究者)。

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