[Translation] A multicenter, randomized, double-blind, controlled, multi-cohort Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, neutralizing antibody levels and immunogenicity of intramuscular GR2001 injection in Chinese adult subjects
I期
主要目的:
评价单次肌肉注射不同剂量GR2001注射液在中国健康成年受试者中的安全性、耐受性。
次要目的:
(1) 评价单次肌肉注射不同剂量GR2001注射液在中国健康成年受试者中的药代动力学特征;
(2)评价单次肌肉注射不同剂量GR2001注射液在中国健康成年受试者中的药效学特征;
(3)评价单次肌肉注射不同剂量GR2001注射液在中国健康成年受试者中的免疫原性特征。
II期
主要目的:
比较肌肉注射不同剂量GR2001注射液联合吸附破伤风疫苗与破伤风人免疫球蛋白联合吸附破伤风疫苗在中国成年受试者中的药效学特征。
次要目的:
(1) 比较肌肉注射不同剂量GR2001注射液联合吸附破伤风疫苗与破伤风人免疫球蛋白联合吸附破伤风疫苗在中国成年受试者中的安全性;
(2)比较肌肉注射不同剂量GR2001注射液联合吸附破伤风疫苗与安慰剂联合吸附破伤风疫苗在中国成年受试者中的药效学特征;
(3)比较肌肉注射不同剂量GR2001注射液联合吸附破伤风疫苗在中国成年受试者中的药代动力学特征;
(4)比较肌肉注射不同剂量GR2001注射液联合吸附破伤风疫苗在中国成年受试者中的免疫原性特征。
[Translation] Phase I
Main objective:
To evaluate the safety and tolerability of a single intramuscular injection of different doses of GR2001 injection in healthy Chinese adult subjects.
Secondary objectives:
(1) To evaluate the pharmacokinetic characteristics of a single intramuscular injection of different doses of GR2001 injection in healthy Chinese adult subjects;
(2) To evaluate the pharmacodynamic characteristics of a single intramuscular injection of different doses of GR2001 injection in healthy Chinese adult subjects;
(3) To evaluate the immunogenicity characteristics of a single intramuscular injection of different doses of GR2001 injection in healthy Chinese adult subjects.
Phase II
Main objective:
To compare the pharmacodynamic characteristics of intramuscular injection of different doses of GR2001 injection combined with adsorbed tetanus vaccine and tetanus human immunoglobulin combined with adsorbed tetanus vaccine in Chinese adult subjects.
Secondary objectives:
(1) To compare the safety of intramuscular injection of different doses of GR2001 injection combined with adsorbed tetanus vaccine and tetanus human immunoglobulin combined with adsorbed tetanus vaccine in Chinese adult subjects;
(2) To compare the pharmacodynamic characteristics of intramuscular injection of different doses of GR2001 injection combined with adsorbed tetanus vaccine and placebo combined with adsorbed tetanus vaccine in Chinese adult subjects;
(3) To compare the pharmacokinetic characteristics of intramuscular injection of different doses of GR2001 injection combined with adsorbed tetanus vaccine in Chinese adult subjects;
(4) To compare the immunogenicity characteristics of intramuscular injection of different doses of GR2001 injection combined with adsorbed tetanus vaccine in Chinese adult subjects.