[Translation] A randomized, double-blind, parallel, placebo-controlled, single-dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous infusion of HSP638DP in healthy subjects
主要目的:评估健康受试者单次静脉输注HSP638DP后的安全性与耐受性,为后期临床试验给药方案提供安全的剂量范围;次要目的:
评价健康受试者单次静脉输注HSP638DP的药代动力学特征,评价健康受试者单次静脉输注HSP638DP的免疫原性;探索性目的:
探索健康受试者静脉输注HSP638DP后的药效学指标。
[Translation] Primary purpose: To evaluate the safety and tolerability of HSP638DP after a single intravenous infusion in healthy subjects, and to provide a safe dosage range for the dosing regimen of later clinical trials; Secondary purpose: To evaluate the pharmacokinetic characteristics of HSP638DP after a single intravenous infusion in healthy subjects, and to evaluate the immunogenicity of HSP638DP after a single intravenous infusion in healthy subjects; Exploratory purpose: To explore the pharmacodynamic indicators of HSP638DP after intravenous infusion in healthy subjects.