[Translation] A multicenter, randomized, double-blind, multiple-dose, dose-escalating, placebo-controlled Phase Ib clinical study of the safety, tolerability, efficacy, pharmacokinetic characteristics and immunogenicity of QX004N in adult patients with moderate to severe plaque psoriasis
主要目的:评价QX004N多次皮下注射在成年中重度斑块状银屑病患者中的安全性、耐受性。
次要目的:评价QX004N多次皮下注射在成年中重度斑块状银屑病患者中的有效性、药代动力学(PK)特征及免疫原性特征。为Ⅱ期临床研究推荐合理的给药方案。
探索性目的:评价QX004N多次皮下注射在成年中重度斑块状银屑病患者中的药效学(PD)特征。
[Translation] Primary objective: To evaluate the safety and tolerability of multiple subcutaneous injections of QX004N in adult patients with moderate to severe plaque psoriasis.
Secondary objective: To evaluate the efficacy, pharmacokinetic (PK) characteristics and immunogenicity characteristics of multiple subcutaneous injections of QX004N in adult patients with moderate to severe plaque psoriasis. Recommend a reasonable dosing regimen for Phase II clinical studies.
Exploratory objective: To evaluate the pharmacodynamic (PD) characteristics of multiple subcutaneous injections of QX004N in adult patients with moderate to severe plaque psoriasis.