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最高研发阶段申请上市 |
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非在研适应症- |
最高研发阶段临床3期 |
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最高研发阶段临床2期 |
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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study on the Efficacy and Safety of hemay005 Tablets in the Treatment of Active Ankylosing Spondylitis
This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study. The study was divided into three stages, including screening period(4-week), treatment period(16-week) and observation period. All subjects need to enter a 28 day (4-week) observation period after stopping hemay005 treatment.
Main purpose:
The efficacy of hemay005 tablet in the treatment of active ankylosing spondylitis (as) was evaluated by placebo parallel control.
Secondary purpose:
To evaluate the safety of oral hemay005 tablets in patients with active as.
To evaluate the population pharmacokinetics of hemay005 tablets in patients with active as.
中国成年男性健康受试者单次口服[14C]Hemay005的人体内物质平衡研究
评价中国成年男性健康受试者单剂量口服[14C]Hemay005的人体内物质平衡,揭示Hemay005在人体内的药代动力学整体特征,为该药的合理使用提供参考。
A Phase Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled To Assess Efficacy and Safety Study of Hemay005 in Subjects With Moderate to Severe Plaque Psoriasis
Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. After single asending dose and mutiple asending dose in health subjects. phase 2 results suggest Hemay005 60 mg BID has a higher curative effect trend,and adverse reactions were mild, so we choose 60 mg BID as Hemay005 phase 3 dosage And the patients with moderate to severe plaque psoriasis will be randomized into 2 cohorts(60mg BID and placebo) approximately 306 subjects will be enrolled (204 in 60mg BID and 102 in placebo). This study includes an 16-week treatment Period, then a 36-week Treatment Period without placebo.
100 项与 天津和美生物技术有限公司 相关的临床结果
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