Clinical trial NCT06041165: A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hyperlipidemia
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 112 days post-dose
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: Up to 48 hours post-dose
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Up to 48 hours post-dose
measure: Terminal Elimination Half-Life (t1/2)
timeFrame: Up to 48 hours post-dose
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: Up to 48 hours post-dose
measure: Angiopoietin-like 3 (ANGPTL3)
timeFrame: Up to 112 days post-dose
measure: Triglycerides
timeFrame: Up to 112 days post-dose
measure: immunogenic characteristics ADA of JS401
timeFrame: Up to 112 days post-dose
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Up to 112 days post-dose
measure: Non-high-density lipoprotein cholesterol (non-HDL-C)
timeFrame: Up to 112 days post-dose
measure: Very low-density lipoprotein cholesterol (VLDL-C)
timeFrame: Up to 112 days post-dose
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: Up to 112 days post-dose
measure: Lipoprotein (a) (Lp(a))
timeFrame: Up to 112 days post-dose
measure: Apolipoprotein B (ApoB)
timeFrame: Up to 112 days post-dose
measure: Apolipoprotein A1 (ApoA1)
timeFrame: Up to 112 days post-dose
measure: Q-T interval
timeFrame: Up to 112 days post-dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: