[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.

Start Date26 Mar 2019

Sponsor / Collaborator

Tonghua Dongbao Biotechnology Co., Ltd.

CTR20170863

/ 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.

Start Date-

Sponsor / Collaborator

Tonghua Dongbao Biotechnology Co., Ltd.

100 Clinical Results associated with Adalimumab biosimilar(Tonghua Dongbao)

100 Translational Medicine associated with Adalimumab biosimilar(Tonghua Dongbao)

100 Patents (Medical) associated with Adalimumab biosimilar(Tonghua Dongbao)

100 Deals associated with Adalimumab biosimilar(Tonghua Dongbao)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 3	China	Tonghua Dongbao Biotechnology Co., Ltd.	26 Mar 2019
Rheumatoid Arthritis	Phase 1	China	Tonghua Dongbao Biotechnology Co., Ltd.	18 Aug 2017

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