A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate safety and tolerability of single ascending dose of CT-P63:
研究概览
简要总结
This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects.
详细描述
CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P63 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability, and pharmacokinetics of CT-P63 will be evaluated 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 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
CT-P63
Single Ascending Dose
干预措施: CT-P63 (Drug)
Placebo
Single Ascending Dose
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate safety and tolerability of single ascending dose of CT-P63:
时间窗: Up to 14 Days
1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs) by CTCAE v5.0 2. Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) by CTCAE v5.0 3. Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction) by CTCAE v5.0
次要结局
- To evaluate the Pharmacokinetic(PK) of CT-P63(Up to 90 Days)
- To evaluate immunogenicity of single ascending dose of CT-P63:(Up to 90 Days)