A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM559 in Healthy Subjects With Single Ascending Dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single dose administration of CM559 in healthy male subjects: Adverse events (AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs), magnetic resonance imaging (MRI), laboratory tests, etc.
研究概览
简要总结
This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects age ≥ 18 years & ≤60 years.
- •Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
排除标准
- •The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
- •Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
- •History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
- •Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening.
- •Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
- •Severe trauma or undergo major surgery within 3 months prior to screening,or planned surgery during the research period.
研究组 & 干预措施
CM559 or matched placebo cohort 5
干预措施: CM559 (Biological)
CM559 or matched placebo cohort 1
干预措施: Placebo (Drug)
CM559 or matched placebo cohort 3
干预措施: Placebo (Drug)
CM559 or matched placebo cohort 2
干预措施: Placebo (Drug)
CM559 or matched placebo cohort 1
干预措施: CM559 (Biological)
CM559 or matched placebo cohort 4
干预措施: Placebo (Drug)
CM559 or matched placebo cohort 5
干预措施: Placebo (Drug)
CM559 or matched placebo cohort 4
干预措施: CM559 (Biological)
CM559 or matched placebo cohort 3
干预措施: CM559 (Biological)
CM559 or matched placebo cohort 2
干预措施: CM559 (Biological)
结局指标
主要结局
Safety and tolerability of single dose administration of CM559 in healthy male subjects: Adverse events (AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs), magnetic resonance imaging (MRI), laboratory tests, etc.
时间窗: Up to 99 Days
All adverse events (AEs) collected from all subjects from the time of signing the informed consent form (ICF) to the completion of the study (or early withdrawal), including clinical manifestations, severity, occurrence time, end time, treatment measures, and outcomes, as well as their correlation with the investigational drug. Any clinically significant abnormalities found during the physical examinations, vital signs examination, ECGs examinations and laboratory tests. The proportion of subjects experienced amyloid-related imaging abnormalities (ARIA) identified by MRI.
次要结局
未报告次要终点