[Translation] A randomized, double-blind, placebo-controlled, single-dose, dose-escalation first-in-human clinical study to evaluate the safety, tolerability and pharmacokinetics of KYS202004A injection in healthy adult subjects
主要目的:评价在健康成年受试者中单次注射不同剂量KYS202004A注射液后的安全性和耐受性。
次要目的:评价在健康成年受试者中单次注射不同剂量KYS202004A注射液后的药代动力学(PK)特征。 评价在健康成年受试者中单次注射不同剂量KYS202004A注射液后的免疫原性的情况。
探索性目的:探索在健康成年受试者中单次注射不同剂量KYS202004A注射液后生物标志物变化。
[Translation] Primary objective: To evaluate the safety and tolerability of KYS202004A injection after a single injection of different doses in healthy adult subjects.
Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of KYS202004A injection after a single injection of different doses in healthy adult subjects. To evaluate the immunogenicity of KYS202004A injection after a single injection of different doses in healthy adult subjects.
Exploratory objective: To explore the changes in biomarkers after a single injection of different doses of KYS202004A injection in healthy adult subjects.