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

Phase 1

Recruiting

• Conditions: Hyperlipidemia
• Interventions: Drug: JS401; Drug: Placebo

• Registration Number: NCT06041165
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-31
• Status Verified: 2023-09
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-06-29
• Study Completion: 2024-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental: JS401 injection	JS401	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	Up to 112 days post-dose	Number of Participants with Adverse Events (AEs)

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	Up to 48 hours post-dose	Peak Plasma Concentration of JS401
Time to Maximum Plasma Concentration (Tmax)	Up to 48 hours post-dose	Time to Maximum Plasma Concentration of JS401
Terminal Elimination Half-Life (t1/2)	Up to 48 hours post-dose	Terminal Elimination Half-Life (t1/2) of JS401
Area Under the Plasma Concentration Versus Time Curve (AUC)	Up to 48 hours post-dose	Area Under the Plasma Concentration Versus Time Curve of JS401
Angiopoietin-like 3 (ANGPTL3)	Up to 112 days post-dose	Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
Triglycerides	Up to 112 days post-dose	Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
immunogenic characteristics ADA of JS401	Up to 112 days post-dose	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.
Lipoprotein (a) (Lp(a))	Up to 112 days post-dose	Reduction in Fasting Lp(a) from Pre-Dose Baseline
Apolipoprotein B (ApoB)	Up to 112 days post-dose	Reduction in Fasting ApoB from Pre-Dose Baseline
Apolipoprotein A1 (ApoA1)	Up to 112 days post-dose	Reduction in Fasting ApoA1 from Pre-Dose Baseline
Low-density lipoprotein cholesterol (LDL-C)	Up to 112 days post-dose	Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Very low-density lipoprotein cholesterol (VLDL-C)	Up to 112 days post-dose	Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline
Non-high-density lipoprotein cholesterol (non-HDL-C)	Up to 112 days post-dose	Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline
High-density lipoprotein cholesterol (HDL-C)	Up to 112 days post-dose	Reduction in Fasting SerumHDL-C from Pre-Dose Baseline
Q-T interval	Up to 112 days post-dose	Change in QTc from baseline

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China