[Translation] A randomized, double-blind, placebo-controlled, phase I/II clinical trial of the safety, tolerability, immunogenicity, PK/PD characteristics and efficacy of the recombinant fully human anti-CD39 monoclonal antibody JS019 in subjects with hypereosinophilia
I期临床研究:评价重组全人源抗CD39单克隆抗体JS019单次、多次静脉输注给药在高嗜酸粒细胞增多症受试者中的安全性、耐受性、PK/PD特征及免疫原性,为II期临床试验提供线索和证据。
II期临床研究:探索重组全人源抗CD39单克隆抗体JS019用于高嗜酸粒细胞增多症受试者的安全性、最佳剂量及疗效趋势,为Ⅲ期临床研究提供线索和证据。
[Translation] Phase I clinical study: Evaluate the safety, tolerability, PK/PD characteristics and immunogenicity of single and multiple intravenous infusions of recombinant fully human anti-CD39 monoclonal antibody JS019 in subjects with hypereosinophilia, and provide clues and evidence for Phase II clinical trials.
Phase II clinical study: Explore the safety, optimal dose and efficacy trend of recombinant fully human anti-CD39 monoclonal antibody JS019 in subjects with hypereosinophilia, and provide clues and evidence for Phase III clinical studies.