The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia
- Registration Number
- NCT04781114
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy.
In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo).
Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 806
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JS002 JS002 Cohort 1: 150 mg/1mL Q2W Subcutaneous(SC); Cohort 2: 300/2mL mg Q4W Subcutaneous(SC); Placebo Placebo Cohort 1: 1mL Q2W Subcutaneous(SC); Cohort 2: 2mL Q4W Subcutaneous(SC);
- Primary Outcome Measures
Name Time Method Change in LDL-C of JS002 Up to 24Weeks after dose administration Percentage change in LDL-C relative to baseline at Week 24
- Secondary Outcome Measures
Name Time Method Change in LDL-C of JS002 Up to 52Weeks after dose administration Percentage change in LDL-C relative to baseline at Week 52
The occurrence of adverse events Up 60Weeks after dose administration Evaluate the change of clinically significant laboratory tests, vital signs, and electrocardiogram
The immunogenicity of JS002 Up 60Weeks after dose administration To evaluate the production time, duration and proportion of anti JS002 antibody (ADA).ADA positive samples are tested for titer and for neutralizing antibody (Nab).
Pharmacokinetics (PD) of JS002 Up 60Weeks after dose administration Evaluation of serum concentrations of free/total PCSK9 and changes from baseline.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).
Other lipid parameters of JS002 Up to Week 24 and 52Weeks after dose administration Percentage change in LDL-C relative to baseline at Week 24 and Week 52
Pharmacokinetics (PK) of JS002 Up 60Weeks after dose administration Evaluation of Serum concentration of JS002.Descriptive statistics include mean (arithmetic mean and geometric mean), standard deviation (SD), coefficient of variation CV% (arithmetic coefficient and geometric coefficient of variation), Median (Median), minimum (Min) and maximum (Max).
Trial Locations
- Locations (57)
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
🇨🇳Fuzhou, Fujian, China
The First Hospital of Lanzhou University City:Lanzhou
🇨🇳Lanzhou, Gansu, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Daqingshi People's Hospital
🇨🇳Daqing, Heilongjiang, China
The First Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
Beijing Tongren Hospital Affiliated to Capital Medical University City:Beijing
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Teda International Cardiovascular Hospital
🇨🇳Tianjin, Tianjin, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The Second People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The central hospital of Dalian
🇨🇳Dalian, Liaoning, China
The People's Hospital of Liaoning Provincial
🇨🇳Shenyang, Liaoning, China
General Hospital of the PLA Northern Theater Command
🇨🇳Shenyang, Liaoning, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, Shanxi, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Xianyang Hospital of Yan 'an University
🇨🇳Xianyang, Shanxi, China
The First Affiliated Hospital of the Air Force Medical University
🇨🇳Xian, Shanxi, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin First Central Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Zhongda Hospital Southeast Universty
🇨🇳Nanjing, Jiangsu, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China