A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..

Hyperlipemia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469673
• Other study ID #: JS002-002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 23, 2019
• Est. completion date: June 28, 2020

Study information

• Verified date: July 2020
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 28, 2020
• Est. primary completion date: May 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent.

2. Age =18 and =65 years old;

3. Body mass index (BMI) =18 and = 30 kg/m2;

4. 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;

5. 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;

6. Fasting triglycerides =4.5 mmol/L;

Exclusion Criteria:

1. Diagnosis of homozygous familial hypercholesterolemia;

2. History of New York heart association (NYHA) defined ? - ? heart failure;

3. History of uncontrolled arrhythmiast;

4. History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;

5. History of stroke or TIA;

6. Uncontrolled hypertension with SBP=160mmHg and/or DBP=100mmHg

7. Type 1 diabetes, or type 2 diabetes that is or poorly controlled(HbA1c> 8.0%);

Related Conditions & MeSH terms

• Hyperlipemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Biological:
• Biological:JS002
Administered by subcutaneous injection
• Placebo
Administered by subcutaneous injection

Locations

Country	Name	City	State
China	Fuwai Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects who develop detectable anti-drug antibodies (ADAs)		Twelve weeks after the last dose
Other	Serum concentrations of JS002		Twelve weeks after the last dose
Other	Change from baseline in proprotein convertase total / free pcsk9		Twelve weeks after the last dose
Primary	Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12		12 weeks after the first dose
Secondary	Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)		Twelve weeks after the last dose
Secondary	Percent change from baseline in Total Cholesterol(TC?HDL-C?non-HDL-C?VLDL-C?Apo B?Apo A1?Lp(a) and TG )		Twelve weeks after the last dose
Secondary	Percentage change from baseline TC/HDL-C ratio		Twelve weeks after the last dose
Secondary	Percent change from baseline in Apolipoprotein B (Apo B)		Twelve weeks after the last dose
Secondary	Percent change from baseline in Apolipoprotein A-I (ApoA-I)		Twelve weeks after the last dose