NCT06267183招募中1 期
A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
Shanghai Synvida Biotechnology Co.,Ltd.1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2024年1月12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
- 53
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;
- •Subjects must have a Body Mass Index in the range of 19~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;
- •Subjects must be in good health as judged by the investigator.
- •Reliable contraception must be assured during and for some time after the trial.
排除标准
- •Subjects with a history of drug or other substance anaphylaxis;
- •Subjects with respiratory symptoms or abnormal respiratory tract;
- •Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
- •Subjects with other diseases or factors with abnormal clinical manifestations;
- •Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;
- •Subjects who smoked more than 5 cigarettes a day in the period before screening;
- •Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;
- •Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;
- •Subjects who used other drugs within a certain period of time before receiving the investigational drug;
- •Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;
- •Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.
- •Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;
- •Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;
- •Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;
- •Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;
- •Any other status in which the investigator deems inappropriate to participate in the present study.
研究组 & 干预措施
SV001
Experimental
干预措施: SV001 (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 1 years
Adverse event type, incidence, duration
次要结局
- Peak time（Tmax）(Approximately 1 years)
- half-life（T1/2）(Approximately 1 years)
- Peak Plasma Concentration (Cmax)(Approximately 1 years)
- Area under the plasma concentration versus time curve (AUC)(Approximately 1 years)
- Immunogenicity(Approximately 1 years)
研究者
研究点 (1)
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