復宏漢霖-B(02696.HK):HLX14用於高危骨折風險的女性絕經後骨質疏鬆症的1期臨牀研究完成首例患者給藥
格隆匯 11 月 9日丨復宏漢霖-B(02696.HK)發佈公告,今日,公司研製的重組抗RANKL全人單克隆抗體注射液HLX14用於高危骨折風險的女性絕經後骨質疏鬆症的1期臨牀研究於中國大陸境內完成首例患者給藥。
根據披露,該研究是一項在男性健康受試者中開展的HLX14的兩階段1期臨牀試驗。第一階段為比較HLX14和歐洲市售的地舒單抗在皮下給藥後的藥物代謝動力學特徵、藥效學、安全性、耐受性和免疫原性的開放、隨機、平行對照、單次給藥、雙臂的預試驗研究。第二階段是一項雙盲、隨機、平行對照、單次給藥、4臂的研究,其主要目的是比較HLX14與美國、歐洲及中國大陸市售的地舒單抗的藥物代謝動力學特徵的相似性,次要目的是評估HLX14與對照藥的藥效學、安全性、耐受性和免疫原性的相似性。
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