[Translation] A randomized, double-blind, placebo-controlled, dose-escalating phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SYN100 injection following a single intravenous infusion in healthy subjects
主要研究目的:评价 SYN100 在健康受试者中单次给药的安全性和耐受性, 为后续临床试验奠定基础。
次要研究目的:评价 SYN100 在中国健康受试者中的药代动力学(PK) 特征;探索 SYN100 在中国健康受试者中的药效动力学(PD)特征;评价 SYN100 在中国健康受试者中的免疫原性(ADA) 特征;评价 SYN100 在中国健康受试者中的安全性特征。
[Translation] Primary study objectives: To evaluate the safety and tolerability of a single dose of SYN100 in healthy subjects, and lay the foundation for subsequent clinical trials.
Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics of SYN100 in healthy Chinese subjects; To explore the pharmacodynamic (PD) characteristics of SYN100 in healthy Chinese subjects; To evaluate the immunogenicity (ADA) characteristics of SYN100 in healthy Chinese subjects; To evaluate the safety characteristics of SYN100 in healthy Chinese subjects.