科笛-B(02487.HK)治療腹部脂肪堆積藥物完成內地I期臨牀
科笛-B(02487.HK)公佈,完成潛在1類新藥CU-20401(重組突變膠原(酉每))用於治療腹部脂肪堆積的I期臨牀試驗。CU-20401在中國進行的用於治療腹部脂肪堆積的I期臨牀試驗共計48名受試者接受治療。該臨牀試驗是一項單中心、開放標籤、安慰劑對照及劑量遞增試驗,以觀察CU-20401的安全性及耐受性。
臨牀試驗數據顯示,CU-20401的整體安全性和耐受性良好,且與劑量無明顯相關性。各劑量組均未發生3級或以上的治療期間發生的不良事件(TEAE)和與研究藥物相關的不良事件(TRAE)、嚴重不良事件(SAE)或導致退出試驗的TEAE和TRAE。此外,所有受試者的血藥濃度均低於檢測下限,顯示皮下注射CU-20401後的系統暴露量極低。
數據亦顯示出初步療效趨勢。在三個月的隨訪期間,隨着時間延長,受試者腹部給藥區域皮下脂肪體積相對基線的降低更加明顯。
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