舒泰神(300204.SZ):STSA-1002注射液(急性呼吸窘迫綜合徵適應症)獲得IbII期臨牀研究總結報告
格隆匯7月8日丨舒泰神(300204.SZ)公佈,近日,舒泰神(北京)生物製藥股份有限公司取得關於STSA-1002注射液(急性呼吸窘迫綜合徵適應症)的Ib/II期臨牀研究總結報告。
本研究中有91.49%受試者報告了給藥後發生的不良事件,其中低劑量組報告率爲93.33%、高劑量組爲94.12%、對照組爲86.67%;34.04%受試者在給藥後報告了嚴重不良事件,其中低劑量組爲40.00%、高劑量組爲11.76%、對照組爲53.33%。本研究未報告導致劑量減低、劑量中斷的不良事件。STSA-1002注射液具有良好的安全性和耐受性。
受試者接受STSA-1002注射液給藥後,各劑量組的平均血藥濃度隨劑量增加而升高,給藥後所有治療組均觀察到遊離C5a均較基線明顯降低,在ARDS患者中免疫原性較低。
綜上,STSA-1002注射液在Ib/II研究中顯示了初步有效性和良好的安全性,支持繼續開展進一步臨牀研究。
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