[Translation] A Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and explore the dosing of CG001 in healthy people/PNH patients
Part 1(健康人剂量递增阶段)主要研究目的:评估健康人接受 CG001 注射后的安全性和耐受性;次要研究目的:评估健康人接受 CG001 注射后的药代动力学(PK)特征;评估健康人接受 CG001 注射后的免疫原性;探索性目的:探索健康人接受 CG001 注射后的药效/免疫学标志物。
Part 2(PNH患者剂量递增阶段)主要研究目的:评估 PNH 患者接受 CG001 注射后的安全性和耐受性;次要研究目的: 评估 PNH 患者接受 CG001 注射后的 PK 特征;评估 PNH 患者接受 CG001 注射后的免疫原性;初步评估 PNH 患者接受 CG001 注射后的有效性;探索性目的:探索PNH患者接受CG001注射后的药效/免疫学标志物。
[Translation] Part 1 (healthy subjects dose escalation phase) Main study objectives: evaluate the safety and tolerability of CG001 after injection in healthy subjects; Secondary study objectives: evaluate the pharmacokinetic (PK) characteristics of CG001 after injection in healthy subjects; evaluate the immunogenicity of CG001 after injection in healthy subjects; Exploratory objectives: explore the pharmacodynamic/immunological markers of CG001 after injection in healthy subjects.
Part 2 (PNH patients dose escalation phase) Main study objectives: evaluate the safety and tolerability of CG001 after injection in PNH patients; Secondary study objectives: evaluate the PK characteristics of CG001 after injection in PNH patients; evaluate the immunogenicity of CG001 after injection in PNH patients; preliminarily evaluate the effectiveness of CG001 after injection in PNH patients; Exploratory objectives: explore the pharmacodynamic/immunological markers of CG001 after injection in PNH patients.