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

NCT06041165 | Unknown Phase 1

• 1 other identifier: JS401-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  Number of Participants with Adverse Events (AEs)

  Up to 112 days post-dose

Secondary Outcomes (15)

• Peak Plasma Concentration (Cmax)

  Up to 48 hours post-dose

• Time to Maximum Plasma Concentration (Tmax)

  Up to 48 hours post-dose

• Terminal Elimination Half-Life (t1/2)

  Up to 48 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve (AUC)

  Up to 48 hours post-dose

• Angiopoietin-like 3 (ANGPTL3)

  Up to 112 days post-dose

Study Arms (2)

Experimental: JS401 injection

EXPERIMENTAL

Drug: JS401

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JS401 DRUG

Single dose of JS401 by subcutaneous (sc) injections

Experimental: JS401 injection

Placebo DRUG

Calculated volume to match active treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fugui Wang

CONTACT

8613511074153; fugui_wang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 18, 2023
• Study Start: August 31, 2023
• Primary Completion: June 29, 2024
• Study Completion: September 21, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)