An Open-label and Dose-escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of HLA-G-targeted Exosome (SOB100) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of adverse event (AE)
研究概览
简要总结
The investigational drug, SOB100, is an HLA-G targeted exosome equipped with a nanobody namely anti-HLA-G VHH on the exosome membrane. This is a Phase I dose escalation study to exam the tolerability, safety, and pharmacokinetics in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged ≥ 18 years old
- •Overtly healthy subject, who is considered to be generally healthy based on medical history, 12-lead ECG, and physical examinations, as judged by the Investigator
- •Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF)
- •Adequate organ function
排除标准
- •With known or suspected to be hypersensitivity to HLA-G related treatment.
- •Confirmed active HIV, HBV, or HCV infection
- •With active fungal, bacterial, viral or atypical infection requiring systemic medication
- •History of cancer (malignancy) or have ever received any anti-cancer therapy
- •Has ever received cell therapy or organ transplantation
- •Substance abuse or addictive use of drugs for nonmedical purposes
- •Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception
- •Male subjects with a female spouse/partner who is of childbearing potential refuse to adopt at least one highly effective method of contraception
研究组 & 干预措施
SOB100
干预措施: SOB100 (Drug)
结局指标
主要结局
Incidence of adverse event (AE)
时间窗: From start until 3 weeks after the last dose of SOB100
Incidence of serious adverse event (SAE)
时间窗: From start until 3 weeks after the last dose of SOB100
Incidence of treatment-emergent adverse event (TEAE)
时间窗: From start until 3 weeks after the last dose of SOB100
Abnormalities in physical examination (PE)
时间窗: From start until 3 weeks after the last dose of SOB100
Abnormalities in ECG
时间窗: From start until 3 weeks after the last dose of SOB100
次要结局
未报告次要终点