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

NCT04469673 | Completed Phase 1

• 1 other identifier: JS002-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Conditions

Hyperlipemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12

  12 weeks after the first dose

Secondary Outcomes (5)

• Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C)

  Twelve weeks after the last dose

• 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

• Percentage change from baseline TC/HDL-C ratio

  Twelve weeks after the last dose

• Percent change from baseline in Apolipoprotein B (Apo B)

  Twelve weeks after the last dose

• Percent change from baseline in Apolipoprotein A-I (ApoA-I)

  Twelve weeks after the last dose

Other Outcomes (3)

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  Twelve weeks after the last dose

• Serum concentrations of JS002

  Twelve weeks after the last dose

• Change from baseline in proprotein convertase total / free pcsk9

  Twelve weeks after the last dose

Study Arms (2)

JS002

EXPERIMENTAL

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

Biological: Biological：JS002

Placebo

PLACEBO COMPARATOR

Participants received matching placebo dose regimens by subcutaneous injection.

Biological: Placebo

Interventions

Biological：JS002 BIOLOGICAL

Administered by subcutaneous injection

JS002

Placebo BIOLOGICAL

Administered by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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%);

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: May 23, 2019
• Primary Completion: May 3, 2020
• Study Completion: June 28, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

CN (1)