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復宏漢霖(02696.HK):伊匹木單抗生物類似藥HLX13(重組抗CTLA-4全人單克隆抗體注射液)在中國健康男性受試者中開展的1期臨牀研究完成首例受試者給藥
格隆匯 12-13 17:50

格隆匯12月13日丨復宏漢霖(02696.HK)宣佈,近日,公司自主研發的伊匹木單抗生物類似藥HLX13(重組抗CTLA-4全人單克隆抗體注射液)("HLX13")在中國健康男性受試者中開展的1期臨牀研究完成首例受試者給藥。

本研究為一項在中國健康成年男性受試者中比較HLX13與伊匹木單抗注射液(YERVOY®,美國市售、歐盟市售和中國市售)的藥代動力學特徵、安全性和免疫原性的隨機、靜脈單次給藥、1期平行研究。本研究分為兩個部分。第一部分是開放標籤、隨機、單次給藥、雙臂的平行研究,旨在評估HLX13與歐盟市售的YERVOY®在單次靜脈輸注後藥代動力學參數、安全性和免疫原性,以優化第二部分的研究設計。第二部分是雙盲、隨機、單次給藥、四臂的平行研究,各組受試者將分別接受靜脈輸注0.3 mg/kg的HLX13,或0.3 mg/kg的美國、歐盟或中國市售的YERVOY®,試驗將評估HLX13和美國、歐盟及中國市售YERVOY®的藥代動力學參數的相似性、安全性和免疫原性。本研究的主要終點為從時間點0至無窮大時間的血藥濃度-時間曲線下面積(AUC0-inf)和峯濃度(Cmax)。次要終點包含其他藥代動力學參數、安全性和免疫原性。

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