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開拓藥業-B(09939.HK):GT20029治療脱髮和痤瘡的美國I期臨牀試驗完成首例受試者給藥
格隆匯 02-03 18:41

格隆匯2月3日丨開拓藥業-B(09939.HK)董事會欣然宣佈,GT20029治療脱髮和痤瘡美國I期臨牀試驗已於當地時間2022年2月1日完成首例受試者入組及給藥。

該臨牀試驗是一項隨機、雙盲、安慰劑對照、平行設計、劑量遞增的研究,以評估GT20029(凝膠)在健康受試者中單次劑量遞增和在雄激素性脱髮或痤瘡受試者中多次劑量遞增後的安全性、耐受性和藥代動力學(PK)等特徵。

GT20029是使用集團自主開發的靶向蛋白降解嵌合體(“PROTAC”)平台開發的首款雄激素受體(“AR”)化合物。據公司所知,它是全球首個進入臨牀階段的外用PROTAC化合物。2021年4月及7月,中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)及美國食品藥品監督管理局(FDA)分別批准GT20029開展I期臨牀試驗,用於雄激素性脱髮和痤瘡的治療。2021年7月28日,GT20029中國I期臨牀試驗完成首批受試者給藥。詳情請參閲公司日期為2021年4月15日、2021年7月13日及2021年7月28日的公吿。

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