NCT06161090已完成1 期
Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity 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 33 人开始时间: 2019年9月3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
- 33
- 试验地点
- 1
- 主要终点
- Adverse event
研究概览
简要总结
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Healthy male volunteers.
- •aged ≥ 18 and ≤ 65 years old.
- •With all clinical laboratory examination normal.
- •Voluntary signing of the informed consent form.
排除标准
- •With a history of asthma and allergic reactions.
- •With a history of conjunctivitis and keratitis, as well as previous medical conditions.
- •With positive results from alcohol breath or urine drug abuse testing.
研究组 & 干预措施
Group 75 mg
Experimental
CM310 Recombinant Humanized Monoclonal Antibody Injection
干预措施: CM310 (Biological)
Group 150 mg
Experimental
CM310 Recombinant Humanized Monoclonal Antibody Injection
干预措施: CM310 (Biological)
Group 300 mg
Experimental
CM310 Recombinant Humanized Monoclonal Antibody Injection
干预措施: CM310 (Biological)
Group 600 mg
Experimental
CM310 Recombinant Humanized Monoclonal Antibody Injection
干预措施: CM310 (Biological)
Placebo
Placebo Comparator
Placebo, Subcutaneous
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse event
时间窗: up to Week 9
Incidence of adverse events.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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