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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041165
• Other study ID #: JS401-001
• Status: Recruiting
• Phase: Phase 1
• Start date: August 31, 2023
• Est. completion date: September 21, 2024

Study information

• Verified date: September 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: Fugui Wang
• Phone: 8613511074153
• Email: fugui_wang[@]junshipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 21, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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:

1. 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;

2. Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization;

3. 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;

4. History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening;

5. History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• JS401
Single dose of JS401 by subcutaneous (sc) injections
• Placebo
Calculated volume to match active treatment

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	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
Primary	Number of Participants with Adverse Events (AEs)	Number of Participants with Adverse Events (AEs)	Up to 112 days post-dose
Secondary	Peak Plasma Concentration (Cmax)	Peak Plasma Concentration of JS401	Up to 48 hours post-dose
Secondary	Time to Maximum Plasma Concentration (Tmax)	Time to Maximum Plasma Concentration of JS401	Up to 48 hours post-dose
Secondary	Terminal Elimination Half-Life (t1/2)	Terminal Elimination Half-Life (t1/2) of JS401	Up to 48 hours post-dose
Secondary	Area Under the Plasma Concentration Versus Time Curve (AUC)	Area Under the Plasma Concentration Versus Time Curve of JS401	Up to 48 hours post-dose
Secondary	Angiopoietin-like 3 (ANGPTL3)	Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	Triglycerides	Reduction in Fasting Serum LDL-C from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	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.	Up to 112 days post-dose
Secondary	Low-density lipoprotein cholesterol (LDL-C)	Reduction in Fasting Serum LDL-C from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	Non-high-density lipoprotein cholesterol (non-HDL-C)	Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	Very low-density lipoprotein cholesterol (VLDL-C)	Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	High-density lipoprotein cholesterol (HDL-C)	Reduction in Fasting SerumHDL-C from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	Lipoprotein (a) (Lp(a))	Reduction in Fasting Lp(a) from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	Apolipoprotein B (ApoB)	Reduction in Fasting ApoB from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	Apolipoprotein A1 (ApoA1)	Reduction in Fasting ApoA1 from Pre-Dose Baseline	Up to 112 days post-dose
Secondary	Q-T interval	Change in QTc from baseline	Up to 112 days post-dose