[Translation] A multicenter, randomized, double-blind, placebo/positive-controlled phase I clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of the first application of rabies monoclonal antibody CBB1 in healthy subjects
1. 评价并比较单次给予不同剂量狂犬单抗 CBB1 或狂犬病人免疫球蛋白(HRIG)后在健康成人中的安全性、耐受性、药代动力学、狂犬病毒中和抗体活性和免疫原性特征。
2. 评价并比较不同剂量狂犬单抗 CBB1 联合疫苗或 HRIG 联合疫苗后在健康成人中的安全性、耐受性、药代动力学、狂犬病毒中和抗体活性和免疫原性特征。
3. 比较不同剂量狂犬单抗 CBB1 单独使用、不同剂量狂犬单抗 CBB1 联合疫苗或 HRIG 联合疫苗使用后在健康成人中的安全性、耐受性、药代动力学、狂犬病毒中和抗体活性和免疫原性特征,进一步评估药物相互作用,为后续临床试验探索最适使用剂量。
[Translation] 1. Evaluate and compare the safety, tolerability, pharmacokinetics, rabies virus neutralizing antibody activity and immunogenicity characteristics of single administration of different doses of rabies monoclonal antibody CBB1 or rabies human immunoglobulin (HRIG) in healthy adults.
2. Evaluate and compare the safety, tolerability, pharmacokinetics, rabies virus neutralizing antibody activity and immunogenicity characteristics of different doses of rabies monoclonal antibody CBB1 combined with vaccine or HRIG combined with vaccine in healthy adults.
3. Compare the safety, tolerability, pharmacokinetics, rabies virus neutralizing antibody activity and immunogenicity characteristics of different doses of rabies monoclonal antibody CBB1 alone, different doses of rabies monoclonal antibody CBB1 combined with vaccine or HRIG combined with vaccine in healthy adults, further evaluate drug interactions, and explore the optimal dose for subsequent clinical trials.