[Translation] Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous injections of HRS-4729 injection in healthy subjects - a randomized, double-blind, dose-escalation, placebo-controlled Phase I clinical study
主要研究目的 :评估单次及多次皮下注射 HRS-4729 注射液在健康受试者中的安全性和耐受性。
次要研究目的 :1、评价单次皮下注射 HRS-4729 注射液在健康受试者中的药代动力学(PK)特征及免疫原性;2、评价多次皮下注射 HRS-4729 注射液在健康受试者中的药代动力学(PK)、药效动力学(PD)特征及免疫原性。
探索性目的:1、评价单次皮下注射 HRS-4729 注射液在健康受试者中的药效动力学(PD)特征;2、评估 HRS-4729 注射液对 QT/QTc 间期的影响;3、探索多次皮下注射 HRS-4729 注射液对对乙酰氨基酚的药代动力学(PK)特征影响;4、探索 HRS-4729 与 HRS9531 的 PD 差异。
[Translation] Primary study objectives: To evaluate the safety and tolerability of single and multiple subcutaneous injections of HRS-4729 injection in healthy subjects.
Secondary study objectives: 1. To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of a single subcutaneous injection of HRS-4729 injection in healthy subjects; 2. To evaluate the pharmacokinetic (PK), pharmacodynamic (PD) characteristics and immunogenicity of multiple subcutaneous injections of HRS-4729 injection in healthy subjects.
Exploratory objectives: 1. To evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of HRS-4729 injection in healthy subjects; 2. To evaluate the effect of HRS-4729 injection on the QT/QTc interval; 3. To explore the effect of multiple subcutaneous injections of HRS-4729 injection on the pharmacokinetic (PK) characteristics of acetaminophen; 4. To explore the PD differences between HRS-4729 and HRS9531.