[Translation] A multicenter, randomized, blinded, controlled phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of a combination of fully human anti-tetanus toxin monoclonal antibodies A82/B86 injection
Ia(单独给药阶段)
主要目的:
评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的安全性、耐受性。
次要目的:
(1)评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的药代动力学特征;
(2)评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的药效学特征;
(3)评价单次肌内注射不同剂量CBL8851注射液在中国健康成年志愿者中的免疫原性特征。
Ib(药物相互作用阶段)
主要目的:
评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的安全性、耐受性。
次要目的:
(1)评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的药效学特征,评估药物相互作用;
(2)评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的药代动力学特征;
(3)评价肌内注射CBL8851注射液联合吸附破伤风疫苗在中国健康成年志愿者中的免疫原性特征。
[Translation] Ia (single administration phase)
Main objective:
To evaluate the safety and tolerability of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers.
Secondary objectives:
(1) To evaluate the pharmacokinetic characteristics of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers;
(2) To evaluate the pharmacodynamic characteristics of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers;
(3) To evaluate the immunogenicity characteristics of a single intramuscular injection of different doses of CBL8851 injection in healthy Chinese adult volunteers.
Ib (drug interaction phase)
Main objective:
To evaluate the safety and tolerability of intramuscular injection of CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers.
Secondary objectives:
(1) To evaluate the pharmacodynamic characteristics of intramuscular CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers and assess drug interactions;
(2) To evaluate the pharmacokinetic characteristics of intramuscular CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers;
(3) To evaluate the immunogenicity characteristics of intramuscular CBL8851 injection combined with adsorbed tetanus vaccine in healthy Chinese adult volunteers.