NCT07469085尚未招募1 期
A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.
Shanghai Synvida Biotechnology Co.,Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月31日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg/m², 18.5 ≤ Caucasian participants ≤ 32 kg/m²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg;
- •Healthy status: No evidence of active or chronic diseases in participants;
- •Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.
排除标准
- •Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;
- •Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study;
- •Subjects with designated examination results reaching a specified value;
- •Subjects with abnormal laboratory test results deemed clinically significant by the investigator;
- •Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody;
- •Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1;
- •Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1;
- •Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening;
- •Subjects who have donated blood or lost blood ≥ 400 mL within 3 months prior to drug administration, or donated blood or lost blood ≥ 200 mL within 1 month, or with a history of blood product use;
- •Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients;
- •Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration;
- •Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding;
- •Chinese female subjects who are postmenopausal or have an irregular menstrual cycle;
- •Female subjects of childbearing potential, or male subjects whose female partners are of childbearing potential, who refuse to adopt reliable contraceptive measures during the study and for 6 months after the last drug administration;
- •Any other factors that the investigator deems may render a subject unsuitable for study participation.
研究组 & 干预措施
SV003
Experimental
干预措施: SV003 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Approximately 3 months
Adverse event type, incidence, duration
次要结局
- Peak time（Tmax）(Approximately 3 months)
- Peak Plasma Concentration (Cmax)(Approximately 3 months)
- Area under the plasma concentration versus time curve (AUC)(Approximately 3 months)
- half-life（T1/2）(Approximately 3 months)
- Immunogenicity(Approximately 3 months)
研究者
研究点 (1)
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