NCT05702450已完成1 期
A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics 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 240 人开始时间: 2023年3月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 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 study to evaluate the pharmacokinetics, safety and immunogenicity 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have the ability to understand the study.
- •Voluntarily participate in the study and sign the ICF.
- •18 years ≤ age ≤ 65 years, male and female.
- •Willing to take effective contraceptive measures during the study period.
排除标准
- •Plan to receive any major surgery during the study period.
- •With malignant tumors within 5 years before screening.
- •Positive results of alcohol breath test or urine drug abuse screening during screening period.
- •Any reason that the investigator believes that will prevent the subject from participating in the study.
研究组 & 干预措施
Group P1
Experimental
CM310, Subcutaneous
干预措施: CM310 (Biological)
Group P2
Active Comparator
CM310, Subcutaneous, as the parallel control group
干预措施: CM310 (Biological)
结局指标
主要结局
Pharmacokinetic: the maximum concentration (Cmax)
时间窗: up to 57 days
Concentration and exposure
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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