Evaluating the effects of JS401 on triglyceride levels in healthy volunteers

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

This study is testing a new drug called JS401 to see if it can lower triglyceride levels in healthy adults with normal or slightly high levels.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06041165 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of JS401 in healthy volunteers who have normal or mildly elevated triglyceride levels. Participants will be closely monitored for any adverse effects and changes in lipid profiles following administration of the drug compared to a placebo. The study will include both male and female subjects aged 18 to 60, ensuring a balanced representation of genders. The trial is designed to gather essential data that could inform future treatments for hyperlipidemia.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 60 with fasting triglyceride levels between 1.1 and 5.0 mmol/L.

Not a fit: Patients with significant underlying health conditions or those requiring hospitalization for infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic options for managing triglyceride levels in patients with hyperlipidemia.

How similar studies have performed: While this approach is focused on a specific drug, similar studies evaluating lipid-lowering agents have shown promising results in the past.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing

• Peking University Third Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fugui Wang

Conditions Hyperlipidemia