[Translation] A randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous injection of EDP167 injection in healthy Chinese adults and those with mild dyslipidemia
主要研究目的:
(1)评价在成年受试者中单次皮下注射 EDP167 的安全性和耐受性。
次要研究目的:
(1)评价在成年受试者中单次皮下注射 EDP167 的药代动力学特征;
(2) 评价在成年受试者中单次皮下注射 EDP167 的药效学特征;
(3) 通过 C-QT 分析评价 EDP167 注射液对 QT 间期的影响;
(4) 初步评价 EDP167 的免疫原性。
探索性研究目的:
(1)评估在成年受试者中单次皮下注射 EDP167 的暴露-效应关系;
(2)评估在成年受试者中单次皮下注射 EDP167 的潜在代谢产物特征。
[Translation] Primary study objectives:
(1) To evaluate the safety and tolerability of a single subcutaneous injection of EDP167 in adult subjects.
Secondary study objectives:
(1) To evaluate the pharmacokinetic characteristics of a single subcutaneous injection of EDP167 in adult subjects;
(2) To evaluate the pharmacodynamic characteristics of a single subcutaneous injection of EDP167 in adult subjects;
(3) To evaluate the effect of EDP167 injection on the QT interval by C-QT analysis;
(4) To preliminarily evaluate the immunogenicity of EDP167.
Exploratory study objectives:
(1) To evaluate the exposure-effect relationship of a single subcutaneous injection of EDP167 in adult subjects;
(2) To evaluate the characteristics of potential metabolites of a single subcutaneous injection of EDP167 in adult subjects.