[Translation] A randomized, double-blind, tetanus immunoglobulin-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of intramuscular GR2001 injection in patients with suspected tetanus exposure
主要目的:评价GR2001注射液在疑似破伤风暴露者中的有效性。次要目的:比较GR2001注射液与HTIG在疑似破伤风暴露者中的临床结局;比较GR2001注射液与HTIG的安全性;评价GR2001注射液在疑似破伤风暴露者中的药代动力学(PK)特征;评价GR2001注射液在疑似破伤风暴露者中的免疫原性。
[Translation] Primary objective: To evaluate the effectiveness of GR2001 injection in patients with suspected tetanus exposure. Secondary objectives: To compare the clinical outcomes of GR2001 injection and HTIG in patients with suspected tetanus exposure; To compare the safety of GR2001 injection and HTIG; To evaluate the pharmacokinetic (PK) characteristics of GR2001 injection in patients with suspected tetanus exposure; To evaluate the immunogenicity of GR2001 injection in patients with suspected tetanus exposure.