"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC - Study Drug for Early Etiotropic Therapy of Coronavirus Infection Caused by the SARS-CoV-2 Virus, Using Heavy-chain Humanized Monoclonal Antibodies, After Single Administration to Adult Patients".
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Occurrence of adverse events (AE)
研究概览
简要总结
A two-stage open-label, prospective, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity study with participation of healthy volunteers in three dose-escalation groups and patients with a confirmed diagnosis of COVID-19.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1/10 therapeutic dose
5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/10 therapeutic dose of the study drug.
干预措施: 1/10 therapeutic dose (Drug)
1/2 therapeutic dose
5 healthy volunteers + 1 healthy replacement volunteer will recieve 1/2 therapeutic dose of the study drug.
干预措施: 1/2 therapeutic dose (Drug)
full therapeutic dose
15 healthy volunteers + 3 healthy replacement volunteers will recieve full therapeutic dose of the study drug.
干预措施: Patients with a verified diagnosis of COVID-19 (Drug)
Patients with a verified diagnosis of COVID-19
10 volunteers with a verified diagnosis of COVID-19 will recieve full therapeutic dose of the study drug.
干预措施: full therapeutic dose (Drug)
结局指标
主要结局
Occurrence of adverse events (AE)
时间窗: within 28 days after administration of the study drug
次要结局
未报告次要终点