Phase 1 Study of TCN-032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety assessment - number of participants with adverse events (AE)
研究概览
简要总结
The purpose of this study is to compare the safety profile in healthy volunteers of a single intravenous administration of TCN-032 as compared with placebo.
详细描述
Influenza is a highly communicable acute respiratory disease that is considered to be one of the major infectious disease threats to the human population. Annual vaccination is generally effective only against those strains included in the vaccine. Because of the frequent emergence of divergent variants and the periodic emergence of strains with novel hemagglutinin and/or neuraminidase surface proteins that can result in global pandemics, the availability of potent antiviral agents for the prevention and/or treatment of influenza remains an urgent clinical and public health priority.
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 volunteers
- •Normal lab tests
排除标准
- •Prior treatment with a monoclonal antibody
结局指标
主要结局
Safety assessment - number of participants with adverse events (AE)
时间窗: 60 days post infusion
Safety will be assessed by physical examinations, vital signs, serial electrocardiograms and clinical laboratory tests (hematology, chemistry and urinalysis). A clinically significant laboratory value will be any abnormal result that is an unexpected or unexplained laboratory value or change in value from the patient's prior values. AEs will be reported by severity and relatedness to study treatment and classified according to MedDRA
次要结局
- Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032(60 days post infusion)
- Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032(60 days post infusion)