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非在研适应症- |
药物最高研发状态临床1/2期 |
首次获批国家/地区- |
首次获批日期- |
评价注射用重组A型肉毒毒素治疗中、重度眉间纹的安全性、免疫原性和有效性的多中心、随机、双盲、安慰剂、阳性对照的Ⅰ/Ⅱ期临床研究
I期:主要目的:评价注射用重组A型肉毒毒素(YY001)治疗中、重度眉间纹的安全性和耐受性
次要目的:评价YY001治疗中、重度眉间纹的免疫原性。初步评价YY001治疗中、重度眉间纹的有效性。
II期:主要目的:评价注射用重组A型肉毒毒素(YY001)治疗中、重度眉间纹的有效性。评价YY001治疗中、重度眉间纹的安全性。
次要目的:评价YY001治疗中、重度眉间纹的其他有效性;评价YY001治疗中、重度眉间纹的其他安全性;评价YY001治疗中、重度眉间纹的免疫原性
A Phase I/II,Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Safety,Efficacy and Immunogenicity of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines
This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.
0 项与 重庆誉颜制药有限公司 相关的专利(医药)