[Translation] A randomized, double-blind, placebo-controlled phase Ib clinical trial to evaluate the tolerability, safety, pharmacokinetics, immunogenicity and preliminary efficacy of GR2002 injection in patients with moderate to severe atopic dermatitis by multiple subcutaneous injections
主要目的
评价GR2002注射液在中、重度特应性皮炎患者中多次皮下注射的耐受性和安全性特征。
次要目的
评价GR2002注射液在中、重度特应性皮炎患者中多次皮下注射的药代动力学特征;
评价GR2002注射液在中、重度特应性皮炎患者中多次皮下注射的初步疗效;
评价GR2002注射液在中、重度特应性皮炎患者中多次皮下注射的免疫原性。
探索目的
探索中、重度特应性皮炎患者中皮下注射GR2002注射液疗效预测的生物标记物。
[Translation] Primary objective
To evaluate the tolerability and safety characteristics of multiple subcutaneous injections of GR2002 injection in patients with moderate to severe atopic dermatitis.
Secondary objective
To evaluate the pharmacokinetic characteristics of multiple subcutaneous injections of GR2002 injection in patients with moderate to severe atopic dermatitis;
To evaluate the preliminary efficacy of multiple subcutaneous injections of GR2002 injection in patients with moderate to severe atopic dermatitis;
To evaluate the immunogenicity of multiple subcutaneous injections of GR2002 injection in patients with moderate to severe atopic dermatitis.
Exploratory objective
To explore biomarkers for predicting the efficacy of subcutaneous injection of GR2002 injection in patients with moderate to severe atopic dermatitis.