[Translation] A randomized, single-blind, placebo-controlled, single-center, single-ascending and multiple-ascending dose Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic characteristics of subcutaneous RBD7022 in subjects with normal or elevated low-density lipoprotein cholesterol
主要目的:评价RBD7022在不同LDL-C水平的受试者中的安全性和耐受性;
次要目的:1)探究RBD7022在LDL-C正常或升高的人群中的PK特点;2)评估RBD7022对受试者血清LDL-C水平的影响;3)评估RBD7022对受试者血清PCSK9水平的影响 探索性目的:1)评估除LDL-C之外的血脂参数(如TC、TG、Lp (a)、HDL-C、非HDL-C、Apo B、Apo A1、Apo A 1/ Apo B 比值)相对于基线变化;2)评估RBD7022单药或联用他汀类药物对LDL-C和PCSK9水平的影响
[Translation] Primary purpose: To evaluate the safety and tolerability of RBD7022 in subjects with different LDL-C levels;
Secondary purpose: 1) To explore the PK characteristics of RBD7022 in subjects with normal or elevated LDL-C; 2) To evaluate the effect of RBD7022 on the serum LDL-C level of subjects; 3) To evaluate the effect of RBD7022 on the serum PCSK9 level of subjects Exploratory purpose: 1) To evaluate the changes in blood lipid parameters other than LDL-C (such as TC, TG, Lp (a), HDL-C, non-HDL-C, Apo B, Apo A1, Apo A 1/ Apo B ratio) relative to baseline; 2) To evaluate the effect of RBD7022 alone or in combination with statins on LDL-C and PCSK9 levels