NCT06041165RecruitingPhase 1
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
Shanghai Junshi Bioscience Co., Ltd.1 site in 1 country44 target enrollmentStarted: August 31, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events (AEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Experimental: JS401 injection
Experimental
Intervention: JS401 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 112 days post-dose
Number of Participants with Adverse Events (AEs)
Secondary Outcomes
- Lipoprotein (a) (Lp(a))(Up to 112 days post-dose)
- Apolipoprotein B (ApoB)(Up to 112 days post-dose)
- Apolipoprotein A1 (ApoA1)(Up to 112 days post-dose)
- 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)
- Triglycerides(Up to 112 days post-dose)
- immunogenic characteristics ADA of JS401(Up to 112 days post-dose)
- Low-density lipoprotein cholesterol (LDL-C)(Up to 112 days post-dose)
- Very low-density lipoprotein cholesterol (VLDL-C)(Up to 112 days post-dose)
- Non-high-density lipoprotein cholesterol (non-HDL-C)(Up to 112 days post-dose)
- High-density lipoprotein cholesterol (HDL-C)(Up to 112 days post-dose)
- Q-T interval(Up to 112 days post-dose)
Investigators
Study Sites (1)
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