[Translation] A randomized, double-blind, placebo-controlled, phase 2/3 operational seamless design clinical study to evaluate the efficacy and safety of subcutaneous injection of HBM9161 in Chinese patients with active, moderate-to-severe thyroid eye disease (TED)
主要目的:初步评价HBM9161 680 mg皮下注射每周给药及每周给药序贯隔周给药共12周的治疗方案在中国活动性、中重度TED患者中的疗效;
次要目的:初步评价HBM9161皮下注射12周在中国TED患者中的安全性,药代动力学(PK),药效学(PD),免疫原性,受试者对研究方案的依从性。
[Translation] Main objective: To preliminarily evaluate the efficacy of HBM9161 680 mg subcutaneously administered weekly and weekly followed by every other week for 12 weeks in Chinese patients with active, moderate-to-severe TED;
Secondary objectives: Preliminary evaluation of the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and subjects' compliance with the study protocol in Chinese TED patients by subcutaneous injection of HBM9161 for 12 weeks.