Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Hyperlipemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
Eligibility Criteria
Inclusion
- Signed informed consent.
- Age ≥18 and ≤65 years old;
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
- Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
- Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
- Fasting triglycerides ≤4.5 mmol/L;
Exclusion
- Diagnosis of homozygous familial hypercholesterolemia;
- History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
- History of uncontrolled arrhythmiast;
- History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
- History of stroke or TIA；
- Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
- Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c\> 8.0%);
Key Trial Info
Start Date :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04469673
Start Date
May 23 2019
End Date
June 28 2020
Last Update
July 14 2020
Active Locations (1)
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1
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, China