[Translation] A phase I, randomized, double-blind, placebo-controlled, single-dose escalation study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HX15001 injection in healthy Chinese subjects.
主要目的:评估中国健康成年受试者单次HX15001给药后的安全性和耐受性;评估中国健康成年受试者单次HX15001给药后的药代动力学特征
次要目的:进一步评估HX15001 的药代动力学特征;评估HX15001 的免疫原性特征;评估药效动力学(PD)生物标志物的表达水平
[Translation] Primary Objective: To evaluate the safety and tolerability of a single dose of HX15001 in healthy adult Chinese subjects; to evaluate the pharmacokinetic characteristics of a single dose of HX15001 in healthy adult Chinese subjects.
Secondary Objectives: To further evaluate the pharmacokinetic characteristics of HX15001; to evaluate the immunogenicity of HX15001; to evaluate the expression levels of pharmacodynamic (PD) biomarkers.