NCT05851066已完成1 期
A Phase 1 Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of VSA003 in Chinese Adult Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse event (AE) and serious adverse event (SAE)
研究概览
简要总结
This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
- •BMI 18.0~28.0 kg/m2
- •Willing to provide written informed consent and to comply with study requirements
- •On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
- •TG> 100 mg/dL
- •LDL-C> 70 mg/dL
排除标准
- •Clinically significant health concerns
- •Regular use of alcohol within one month prior to screening
- •Recent (within 3 months) use of illicit drugs
- •Female with pregnancy or breastfeeding
- •QTcF>450 ms in ECG
- •Donation or loss of whole blood more than 400 ml prior to administration of the study treatment
- •Note: additional inclusion/exclusion criteria may apply, per protocol
研究组 & 干预措施
VSA003
Experimental
single dose of VSA003 by subcutaneous (sc) injections: 50 mg, 100 mg, 200 mg
干预措施: VSA003 (Drug)
placebo
Placebo Comparator
sterile normal saline (0.9% NaCl) calculated volume to match active treatment
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
Frequency and severity of adverse event (AE) and serious adverse event (SAE)
时间窗: Up to 85±3 days post-dose
safety and tolerability
次要结局
- Maximum observed concentration (Cmax) of VSA003(Up to 48 hours post dose)
- Time of occurrence of Cmax (tmax) of VSA003(Up to 48 hours post dose)
- Apparent terminal phase half-life (t1/2) of VSA003(Up to 48 hours post dose)
- Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA003(Up to 48 hours post dose)
- Apparent clearance (CL/F) of VSA003(Up to 48 hours post dose)
- Apparent terminal phase volume of distribution (Vz/F) of VSA003(Up to 48 hours post dose)
- Change of fasting serum ANGPTL3 from pre-dose baseline(Up to 85±3 days post-dose)
- Anti-drug Antibodies (ADA) to VSA003(Up to 85±3 days post-dose)
研究者
研究点 (1)
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