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

NCT ID: NCT04469673

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-23
• Study Completion Date: 2020-06-28

Brief Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Conditions

Hyperlipemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JS002

Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses.

Group Type: EXPERIMENTAL

Biological：JS002

Intervention Type: BIOLOGICAL

Administered by subcutaneous injection

Placebo

Participants received matching placebo dose regimens by subcutaneous injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Administered by subcutaneous injection

Interventions

Biological：JS002

Administered by subcutaneous injection

Intervention Type: BIOLOGICAL

Placebo

Administered by subcutaneous injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 Ⅱ - Ⅳ 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%);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

JS002-002

Identifier Type: -

Identifier Source: org_study_id