NCT06171048尚未招募1 期
A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2024年4月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Pharmacokinetic: the maximum concentration (Cmax)
研究概览
简要总结
This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.
详细描述
This study includes screening and treatment and follow-up periods.
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
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •20 years ≤ age ≤ 45 years.
- •Voluntarily participate in the study and sign the ICF.
- •Have the ability to understand the study.
排除标准
- •With history of chronic or serious illness.
- •With any medication within 28 days prior to administration;
- •Plan to undergo surgery during the research period;
- •With any situations unsuitable to participate in this study.
结局指标
主要结局
Pharmacokinetic: the maximum concentration (Cmax)
时间窗: up to week 6
Concentration and exposure
次要结局
未报告次要终点
研究者
研究点 (1)
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