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廣生堂(300436.SZ):乙肝治療創新藥GST-HG131完成II期臨牀試驗計劃例數入組
格隆匯 01-22 18:06

格隆匯1月22日丨廣生堂(300436.SZ)公佈,公司創新藥控股子公司福建廣生中霖生物科技有限公司的乙肝治療創新藥GST-HG131已按照II期臨牀方案要求完成了計劃例數全部的感染患者入組。

GST-HG131片II期臨牀試驗由中國人民解放軍總醫院第五醫學中心擔任組長單位開展研究,PI為王福生院士,是“評價GST-HG131片在慢性乙型肝炎患者中的安全性、有效性的隨機、雙盲、安慰劑對照的II期臨牀研究”,旨在評價GST-HG131片在慢性乙型肝炎患者中的安全性、耐受性、PK和初步PD特徵,以對血漿表面抗原的作用作為主要終點。本研究將為GST-HG131的後期臨牀開發試驗設計和給藥劑量方案的確定提供依據。本研究計劃納入45例慢性乙型肝炎患者,共分為3組。截至目前,GST-HG131片II期臨牀試驗已按計劃完成全部3組患者入組。

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