NCT05757596已完成1 期
A Phase 1 Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of a Single Dose of VSA001 Injection in Chinese Healthy Adult 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
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.
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
- Double (Participant, Investigator)
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
- •The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with the requirements of the protocol.
- •Healthy male and female subjects aged between 18 and 55 years (both inclusive) at the time of informed consent.
- •Body mass index (BMI) = weight (kg)/height (m)2, within the range of 19.0-30.0 kg/m2 (both inclusive), and body weight no less than 50 kg.
- •In good general health and without clinically significant abnormalities as judged by the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory results.
- •Negative serum pregnancy test within 72 h prior to initiation of study treatment in all premenopausal females and females who have been amenorrheic for less than 12 months. (Serum pregnancy test is not required for females who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy).
- •Subjects and their partners must agree to use adequate contraceptive methods prior to initiation of study treatment, during the study, and for at least 3 months after discontinuation of study treatment.
- •Fasting serum TGs >80 mg/dL (>0.903 mmol/L) at screening.
排除标准
- •History or presence of significant or clinically significant diseases/abnormality, including but not limited to cardiac/cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, gallbladder, dermatological, hematological, immunological, neurologic, or psychiatric diseases/abnormality, or the disease that, in the judgement of the investigator, present a safety concern or affects the pharmacokinetic evaluation.
- •A family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
- •Subjects who are with acute exacerbation of any significant acute or chronic disease as judged by the investigator.
- •AST and ALT >2×upper limit of normal (ULN) , or total bilirubin >ULN at screening.
- •Serum creatinine estimated eGFR < 60 ml/min/1.73 m2 per MDRD formula.
- •Cardiac troponin (troponin I) above ULN at Screening.
- •Fasting serum TGs >300 mg/dL (>3.38 mmol/L) at screening.
- •Presence of other conditions or treatments that may affect the study results and interfere with the subject's participation in the study as assessed by the investigator.
研究组 & 干预措施
VSA001 injection
Active Comparator
A single dose of active drug (VSA001, low or high dose) will be administered by subcutaneous injection on Day 1.
干预措施: VSA001 injection (Drug)
Placebo
Placebo Comparator
The placebo is normal saline (0.9%) administered subcutaneously; volume matched to the corresponding VSA001 dose volume.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 85 days
Incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with VSA-01001. Clinically significant abnormalities in laboratory tests, vital signs, physical examination, 12-lead electrocardiograms (ECG).
次要结局
- Pharmacokinetics parameter: Cmax(48 hours)
- Pharmacokinetics parameter: Tmax(48 hours)
- Pharmacokinetics parameter: CL/F(48 hours)
- Pharmacodynamic (PD) parameters(85 days)
- Pharmacokinetics parameter: AUC0-t(48 hours)
- Pharmacokinetics parameter: t1/2(48 hours)
- Pharmacokinetics parameter: Vz/F(48 hours)
研究者
研究点 (1)
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