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A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401

Primary Purpose

Hyperlipidemia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JS401
Placebo
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male or female subjects aged 18~60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender; Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening> 1.8 mmol/L (70 mg/dL). Exclusion Criteria: Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials; Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization; Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening; History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening; History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: JS401 injection

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events (AEs)
Number of Participants with Adverse Events (AEs)

Secondary Outcome Measures

Peak Plasma Concentration (Cmax)
Peak Plasma Concentration of JS401
Time to Maximum Plasma Concentration (Tmax)
Time to Maximum Plasma Concentration of JS401
Terminal Elimination Half-Life (t1/2)
Terminal Elimination Half-Life (t1/2) of JS401
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area Under the Plasma Concentration Versus Time Curve of JS401
Angiopoietin-like 3 (ANGPTL3)
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
Triglycerides
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
immunogenic characteristics ADA of JS401
The number and percentage of subjects who were positive for anti-JS401 anti-drug antibody (ADA) after administration of JS401 injection were counted, and the titer of ADA-positive samples was analyzed.
Low-density lipoprotein cholesterol (LDL-C)
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Non-high-density lipoprotein cholesterol (non-HDL-C)
Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline
Very low-density lipoprotein cholesterol (VLDL-C)
Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline
High-density lipoprotein cholesterol (HDL-C)
Reduction in Fasting SerumHDL-C from Pre-Dose Baseline
Lipoprotein (a) (Lp(a))
Reduction in Fasting Lp(a) from Pre-Dose Baseline
Apolipoprotein B (ApoB)
Reduction in Fasting ApoB from Pre-Dose Baseline
Apolipoprotein A1 (ApoA1)
Reduction in Fasting ApoA1 from Pre-Dose Baseline
Q-T interval
Change in QTc from baseline

Full Information

First Posted
September 1, 2023
Last Updated
September 15, 2023
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06041165
Brief Title
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401
Official Title
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Kinetic Effects in Healthy Volunteers With Normal or Mildly Elevated Triglycerides
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
June 29, 2024 (Anticipated)
Study Completion Date
September 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: JS401 injection
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
JS401
Intervention Description
Single dose of JS401 by subcutaneous (sc) injections
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Calculated volume to match active treatment
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Description
Number of Participants with Adverse Events (AEs)
Time Frame
Up to 112 days post-dose
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Peak Plasma Concentration of JS401
Time Frame
Up to 48 hours post-dose
Title
Time to Maximum Plasma Concentration (Tmax)
Description
Time to Maximum Plasma Concentration of JS401
Time Frame
Up to 48 hours post-dose
Title
Terminal Elimination Half-Life (t1/2)
Description
Terminal Elimination Half-Life (t1/2) of JS401
Time Frame
Up to 48 hours post-dose
Title
Area Under the Plasma Concentration Versus Time Curve (AUC)
Description
Area Under the Plasma Concentration Versus Time Curve of JS401
Time Frame
Up to 48 hours post-dose
Title
Angiopoietin-like 3 (ANGPTL3)
Description
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
Triglycerides
Description
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
immunogenic characteristics ADA of JS401
Description
The number and percentage of subjects who were positive for anti-JS401 anti-drug antibody (ADA) after administration of JS401 injection were counted, and the titer of ADA-positive samples was analyzed.
Time Frame
Up to 112 days post-dose
Title
Low-density lipoprotein cholesterol (LDL-C)
Description
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
Non-high-density lipoprotein cholesterol (non-HDL-C)
Description
Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
Very low-density lipoprotein cholesterol (VLDL-C)
Description
Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
High-density lipoprotein cholesterol (HDL-C)
Description
Reduction in Fasting SerumHDL-C from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
Lipoprotein (a) (Lp(a))
Description
Reduction in Fasting Lp(a) from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
Apolipoprotein B (ApoB)
Description
Reduction in Fasting ApoB from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
Apolipoprotein A1 (ApoA1)
Description
Reduction in Fasting ApoA1 from Pre-Dose Baseline
Time Frame
Up to 112 days post-dose
Title
Q-T interval
Description
Change in QTc from baseline
Time Frame
Up to 112 days post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male or female subjects aged 18~60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender; Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening> 1.8 mmol/L (70 mg/dL). Exclusion Criteria: Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials; Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization; Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening; History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening; History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fugui Wang
Phone
8613511074153
Email
fugui_wang@junshipharma.com
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangfang Wang, PhD
Phone
8615611963416
Email
doctorfancy@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401

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