君實生物(01877.HK):JS005中國I期臨牀研究NCT04220073完成首例患者給藥
格隆匯5月25日丨君實生物-B(01877.HK)發佈公告,重組人源化抗IL-17A單克隆抗體注射液(項目代號“JS005”)在中國開展的I期臨牀研究NCT04220073已完成首例患者給藥。該研究旨在評價JS005單次給藥在健康志願者中的耐受性、安全性、藥代動力學(PK)特徵和免疫原性。
根據披露,IL-17A是一種具有多效性的細胞因子,其分泌失調與自身免疫性疾病如銀屑病、類風濕關節炎、強直性脊柱炎等疾病的發生發展密切相關。JS005通過與IL-17A 高親和力結合並選擇性地阻斷IL-17A與其受體IL-17RA/IL-17RC的結合,從而阻斷下游信號通路的啟動和炎性因子的釋放,緩解疾病症狀。JS005與已上市的司庫奇尤單抗和依奇珠單抗兩個同靶點產品的互補決定區(CDR)的氨基酸序列不同,臨牀前研究數據充分顯示:JS005靶點明確、療效確切、安全性良好、生產工藝穩定、產品質量可控,有望成為療效更佳和臨牀應用更廣的IL-17介導的自身免疫病治療藥物。
2019年8月,JS005獲得國家藥品監督管理局簽發的藥物臨牀試驗通知書。2020年5月,公司在中國開展的I期臨牀研究(NCT04220073)完成首例患者給藥。
此外,NCT04220073研究是一項在中國開展的隨機、雙盲、安慰劑對照的I期臨牀研究,該研究一共預設5個劑量組,腹部皮下注射單次給藥。NCT04220073研究計劃共入組40例受試者,每個劑量組分別入組8例受試者,若單次給藥劑量遞增至預設的最高劑量時,仍未觀察到安全終點,經研究者和申辦方共同決定後,可考慮繼續探索更高劑量。該研究主要評價指標為耐受性和安全性,次要評價指標為免疫原性及藥代動力學特徵(PK)等。
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