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开拓药业-B(09939.HK):福瑞他恩治疗雄激素性脱发美国II临试完成首例患者入组及给药
格隆汇 03-01 17:48

格隆汇3月1日丨开拓药业-B(09939.HK)发布公吿,其自主研发、潜在全球同类首创的福瑞他恩(KX-826)治疗男性雄激素性脱发(AGA)的美国II期临床试验已于2022年2月28日完成首例受试者入组及给药。

根据披露,该II期临床试验是一项随机、双盲、安慰剂对照、平行分组研究,计划入组120例受试者,旨在探索福瑞他恩在治疗男性雄激素性脱发受试者时的有效性和安全性。临床试验的主要终点为于24周末,与安慰剂组相比,目标区域内非毳毛数量对比基线的变化。

此外,福瑞他恩治疗AGA的中国临床试验也在推进。于2021年12月31日完成男性III期试验的首例受试者入组,试验有26家中心参与。于2021年11月12日完成女性II期试验的首例受试者入组。

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