[Translation] A multicenter, randomized, double-blind, parallel, positive-controlled Phase III clinical trial to evaluate the equivalence of SYS6012 injection and secukinumab injection (Cosentyx®) in the treatment of moderate to severe plaque psoriasis

验证SYS6012注射液与可善挺®治疗中度至重度斑块状银屑病患者的一致性。

[Translation]

To verify the consistency of SYS6012 injection and Cosentyx® in the treatment of patients with moderate to severe plaque psoriasis.

Start Date20 Jun 2024

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

CTR20233862 / CompletedPhase 1

比较健康男性受试者单次皮下注射SYS6012注射液和原研药后的随机、双盲、平行对照的药代动力学、安全性和免疫原性的I期研究

[Translation] A randomized, double-blind, parallel-controlled phase I study comparing the pharmacokinetics, safety, and immunogenicity of SYS6012 injection and the original drug after a single subcutaneous injection in healthy male subjects

主要目的：考察生物类似药SYS6012注射液的药代动力学特征，并以原研药为参照药，比较健康男性受试者皮下注射两制剂后的主要药代动力学参数，评价两制剂的药代动力学相似性。次要目的：比较生物类似药SYS6012注射液和原研药在健康男性受试者中单次皮下注射1ml:150mg后的安全性和免疫原性。

[Translation]

Primary objective: To investigate the pharmacokinetic characteristics of the biosimilar SYS6012 injection, and to compare the main pharmacokinetic parameters of the two preparations after subcutaneous injection in healthy male subjects with the original drug as the reference drug, and to evaluate the pharmacokinetic similarity of the two preparations. Secondary objective: To compare the safety and immunogenicity of the biosimilar SYS6012 injection and the original drug after a single subcutaneous injection of 1ml:150mg in healthy male subjects.

Start Date30 Nov 2023

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

100 Clinical Results associated with Secukinumab Biosimilar(CSPC Jushi Biomedicine)

100 Translational Medicine associated with Secukinumab Biosimilar(CSPC Jushi Biomedicine)

100 Patents (Medical) associated with Secukinumab Biosimilar(CSPC Jushi Biomedicine)

100 Deals associated with Secukinumab Biosimilar(CSPC Jushi Biomedicine)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 3	CN	CSPC Megalith Biopharmaceutial Co., Ltd.	20 Jun 2024

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