[Translation] An open-label, single-dose, dose-escalation, and dose-expansion Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAL061 in patients with heterozygous familial hypercholesterolemia (HeFH)
主要目的:
评价在HeFH患者中给予SAL061后的安全性和耐受性;
次要目的:
(1)评价在HeFH患者中给予SAL061后的药代动力学特征;
(2)评价在HeFH患者中给予SAL061后的药效学特征;
(3)评价在HeFH患者中给予SAL061后的初步有效性;
(4)评价在HeFH患者中给予SAL061后的免疫原性。
[Translation] Primary objectives:
To evaluate the safety and tolerability of SAL061 in HeFH patients;
Secondary objectives:
(1) To evaluate the pharmacokinetic characteristics of SAL061 in HeFH patients;
(2) To evaluate the pharmacodynamic characteristics of SAL061 in HeFH patients;
(3) To evaluate the preliminary efficacy of SAL061 in HeFH patients;
(4) To evaluate the immunogenicity of SAL061 in HeFH patients.