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非在研适应症- |
最高研发阶段临床1/2期 |
首次获批国家/地区- |
首次获批日期- |
/ Not yet recruiting临床1/2期 A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of Recombinant Botulinum Toxin Type a (JHM03) in Adult Patients with Upper Limb Spasticity
This is a phase Ib/II clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type A（JHM03）in adult patients with upper limb spasticity. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo in adult patients with upper limb spasticity.
注射用重组A型肉毒毒素（JHM03）治疗成人上肢痉挛状态的安全性和有效性的Ⅰb/Ⅱ期临床研究
Ib 期阶段主要目的：评价注射用重组 A 型肉毒毒素（JHM03）治疗成人上肢痉挛状态的耐受性和安全性。
次要目的：评价注射用重组 A 型肉毒毒素（JHM03）治疗成人上肢痉挛状态的免疫原性。初步探索注射用重组 A 型肉毒毒素（JHM03）对于改善成人上肢痉挛状态的有效性。
II 期阶段主要目的： 评价注射用重组 A 型肉毒毒素（JHM03）对于改善成人上肢痉挛状态在给药后第 4 周主要治疗目标肌群改良 Ashworth 量表（Modified Ashworth Scale, MAS）评分的有效性。
次要目的：评价注射用重组 A 型肉毒毒素（ JHM03）对于改善成人上肢痉挛状态在上肢各肌群MAS 评分、 改良 Tardieu 量表（Modified Tardieu scale， MTS）中的肌肉反应角度、 残疾评定量表（Disability Assessment Scale, DAS）、医师整体评估量表（Physician's GlobalAssessment, PGA） 的有效性。评价注射用重组A 型肉毒毒素（JHM03）治疗成人上肢痉挛状态的安全性和免疫原性。
A Phase I/II, Randomized, Double-blind, Placebo, and Active Controlled Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of JHM03 in Subjects With 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 JHM03 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The purpose of this study was to observe efficacy and safety of JHM03 compared with placebo and BOTOX® in moderate to severe glabellar lines.
100 项与 君合盟生物制药（通化）有限公司 相关的临床结果
0 项与 君合盟生物制药（通化）有限公司 相关的专利（医药）
100 项与 君合盟生物制药（通化）有限公司 相关的药物交易
100 项与 君合盟生物制药（通化）有限公司 相关的转化医学
