NCT06041165招募中1 期
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 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年8月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Experimental: JS401 injection
Experimental
干预措施: JS401 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to 112 days post-dose
Number of Participants with Adverse Events (AEs)
次要结局
- 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)
研究者
研究点 (1)
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