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MechanismTNF-α inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Active, not recruitingPhase 3 随机双盲、多中心、阳性药平行对照比较DB101与修美乐在中重度斑块状银屑病患者中有效性及安全性的III期临床研究
[Translation] A randomized, double-blind, multicenter, active drug parallel controlled phase III clinical study comparing the efficacy and safety of DB101 and Humira in patients with moderate to severe plaque psoriasis
比较DB101和阿达木单抗注射液(修美乐®)治疗斑块状银屑病的有效性,确定两者的疗效是否等效;评价比较DB101和阿达木单抗注射液(修美乐®)治疗斑块状银屑病的安全性、耐受性、免疫原性和药代动力学特征。
[Translation] To compare the effectiveness of DB101 and adalimumab injection (Humira®) in the treatment of plaque psoriasis and determine whether the two have equivalent efficacy; to evaluate and compare the safety, tolerability, immunogenicity, and pharmacokinetic characteristics of DB101 and adalimumab injection (Humira®) in the treatment of plaque psoriasis.
/ Not yet recruitingPhase 1 中国健康受试者中单中心、随机、双盲、平行对照设计,DB101与修美乐单次给药比较药代动力学临床试验
[Translation] A single-center, randomized, double-blind, parallel-controlled clinical trial comparing the pharmacokinetic performance of DB101 and Humira in healthy Chinese subjects
比较中国健康受试者单次皮下注射试验用药DB101与参照药修美乐®药代动力学相似性为主要目的;比较中国健康受试者单次皮下注射试验用药DB101与参照药修美乐®安全性和免疫原性为次要目的。
[Translation] The primary objective is to compare the pharmacokinetic similarity of the investigational drug DB101 and the reference drug Humira® after a single subcutaneous injection in healthy Chinese subjects; the secondary objective is to compare the safety and immunogenicity of the investigational drug DB101 and the reference drug Humira® after a single subcutaneous injection in healthy Chinese subjects.
100 Clinical Results associated with Tonghua Dongbao Biotechnology Co., Ltd.
0 Patents (Medical) associated with Tonghua Dongbao Biotechnology Co., Ltd.
100 Deals associated with Tonghua Dongbao Biotechnology Co., Ltd.
100 Translational Medicine associated with Tonghua Dongbao Biotechnology Co., Ltd.