[Translation] A randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of Pagantiangitide for injection in healthy subjects
1、主要目的:评价注射用派格安替安吉肽在健康受试者中的安全性和耐受性;评价注射用派格安替安吉肽在健康受试者中的药代动力学(PK)特征。2、次要目的:评价注射用派格安替安吉肽在健康受试者中的免疫原性。3、探索性目的:探索注射用派格安替安吉肽用药后生物标志物的变化情况;探索注射用派格安替安吉肽的量-效(暴露-效应)关系
[Translation] 1. Primary objective: To evaluate the safety and tolerability of Pegantiangitide for injection in healthy subjects; To evaluate the pharmacokinetic (PK) characteristics of Pegantiangitide for injection in healthy subjects. 2. Secondary objective: To evaluate the immunogenicity of Pegantiangitide for injection in healthy subjects. 3. Exploratory objective: To explore the changes in biomarkers after administration of Pegantiangitide for injection; To explore the dose-effect (exposure-effect) relationship of Pegantiangitide for injection