Phase 1 Study of TCN-202 (Human Anti-Cytomegalovirus Monoclonal Antibody) in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number and severity of adverse events
研究概览
简要总结
The purpose of this study is to compare the safety profile in healthy adult volunteers of single or multiple intravenous administrations of TCN-202 as compared with placebo.
详细描述
Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated prevalence of congenital HCMV infection is ~1% and is one of the leading causes of permanent hearing loss and neurological deficits in children. In immunocompromised individuals such as transplant recipients it can cause serious life-threatening disease and may significantly increase the risk of graft rejection. As existing therapies for HCMV can have serious side effects, there remains a medical need for safe and effective treatment of HCMV disease.
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
- 是
入选标准
- •Healthy adult volunteers
- •Normal lab tests
排除标准
- •Prior treatment with monoclonal antibody
结局指标
主要结局
Number and severity of adverse events
时间窗: 60 days post infusion
Adverse events will be determined by physical examinations, vital signs, serial electrocardiograms, and clinical laboratory abnormalities (hematology, chemistry, and urinalysis).
次要结局
- Peak serum concentration (Cmax) of TCN-202(1 day post infusion)
- Number of subjects who develop anti-TCN-202 anti-drug antibodies (immunogenicity)(60 days post infusion)
- Area under the concentration time curve (AUC) of TCN-202(60 days post infusion)
- Time to maximum serum concentration (Tmax) of TCN-202(1 day post infusion)