6
Clinical Trials associated with SYH2053 / Not yet recruitingPhase 3 A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection as Monotherapy in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia .
This trial plans to enroll 760 Participants.
/ Not yet recruitingPhase 3 A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial
Heterozygous Familial Hypercholesterolemia (HeFH) is an autosomal dominant disorder characterized by markedly elevated low-density lipoprotein cholesterol (LDL-C) and increased risk of atherosclerotic cardiovascular disease (ASCVD). This trial aims to evaluate the SYH2053 Injection in patients with HeFH.
一项在中国低密度脂蛋白胆固醇正常或升高参与者中评价SYH2053注射液对阿托伐他汀钙片药代动力学影响的I期临床试验
[Translation] A phase I clinical trial evaluating the effect of SYH2053 injection on the pharmacokinetics of atorvastatin calcium tablets in Chinese participants with normal or elevated low-density lipoprotein cholesterol
主要目的:在中国低密度脂蛋白胆固醇正常或升高参与者中评价SYH2053注射液对阿托伐他汀钙片药代动力学(PK)的影响;
次要目的:
在中国低密度脂蛋白胆固醇正常或升高参与者中评价SYH2053注射液单次给药后的PK特征;
在中国低密度脂蛋白胆固醇正常或升高参与者中评价SYH2053注射液单次给药后的药效动力学(PD)和探索性生物标志物的变化特征;
在中国低密度脂蛋白胆固醇正常或升高参与者中评价SYH2053注射液单次给药后的免疫原性;
在 在中国低密度脂蛋白胆固醇正常或升高参与者中评价SYH2053注射液和阿托伐他汀钙片的安全性和耐受性。
[Translation] Primary objective: To evaluate the effect of SYH2053 injection on the pharmacokinetics (PK) of atorvastatin calcium tablets in Chinese participants with normal or elevated LDL cholesterol;
Secondary objectives:
To evaluate the PK characteristics of SYH2053 injection after a single dose in Chinese participants with normal or elevated LDL cholesterol;
To evaluate the pharmacodynamics (PD) and exploratory biomarker changes of SYH2053 injection after a single dose in Chinese participants with normal or elevated LDL cholesterol;
To evaluate the immunogenicity of SYH2053 injection after a single dose in Chinese participants with normal or elevated LDL cholesterol;
To evaluate the safety and tolerability of SYH2053 injection and atorvastatin calcium tablets in Chinese participants with normal or elevated LDL cholesterol.
100 Clinical Results associated with SYH2053
100 Translational Medicine associated with SYH2053
100 Patents (Medical) associated with SYH2053
100 Deals associated with SYH2053