A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Emergency adverse events during treatment
研究概览
简要总结
This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.
详细描述
The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years and ≤ 65 years, healthy male.
- •With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
- •Subjects can communicate well with investigators and comply with protocol requirements.
排除标准
- •Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
- •Major surgery is planned during the study period.
- •The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
- •Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
- •There are any reasons that the investigator believes will prevent the subject from participating in the study.
研究组 & 干预措施
Group 1
CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose
干预措施: CM326 (Biological)
Group 1
CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose
干预措施: Placebo (Other)
Group 2
CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose
干预措施: CM326 (Biological)
Group 2
CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose
干预措施: Placebo (Other)
Group 3
CM326 220mg/2mL or matched placebo, subcutaneous at high dose
干预措施: CM326 (Biological)
Group 3
CM326 220mg/2mL or matched placebo, subcutaneous at high dose
干预措施: Placebo (Other)
Group 4
CM326 220mg/2mL or matched placebo, subcutaneous at medium dose
干预措施: CM326 (Biological)
Group 4
CM326 220mg/2mL or matched placebo, subcutaneous at medium dose
干预措施: Placebo (Other)
结局指标
主要结局
Emergency adverse events during treatment
时间窗: Up to week 12
By assessing the number and severity of adverse events during the study.
次要结局
未报告次要终点