[Translation] A randomized, double-blind, placebo-controlled, dose-escalation, single-dose and multiple-dose Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic properties, and immunogenicity of HEC-648 injection in healthy participants.
主要目的:
1)评价 HEC-648 注射液在健康试验参与者中单次和多次给药的安全性和耐受性。
次要目的:
1)评价 HEC-648 注射液在健康试验参与者中单次和多次给药的药代动力学特征。
2)评价 HEC-648 注射液在健康试验参与者中单次和多次给药的免疫原性。
3)评价 HEC-648 注射液在健康试验参与者中单次和多次给药后的药效学特征。
[Translation] Primary Objectives:
1) To evaluate the safety and tolerability of HEC-648 injection after single and multiple administrations in healthy trial participants.
Secondary Objectives:
1) To evaluate the pharmacokinetic characteristics of HEC-648 injection after single and multiple administrations in healthy trial participants.
2) To evaluate the immunogenicity of HEC-648 injection after single and multiple administrations in healthy trial participants.
3) To evaluate the pharmacodynamic characteristics of HEC-648 injection after single and multiple administrations in healthy trial participants.