NCT07292688
招募中
1 期
A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CM383 Following Intravenous and Subcutaneous Administration in Healthy Adult Subjects
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月1日最近更新:
干预措施CM383
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Keymed Biosciences Co.Ltd
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects
概览
简要总结
This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.
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 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects age ≥ 18 years \& ≤54 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 400 mL, 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 6 months prior to screening, or planned surgery during the research period.
研究组 & 干预措施
CM383 subcutaneous injection group 1
Experimental
干预措施: CM383 (Biological)
CM383 subcutaneous injection group 2
Experimental
干预措施: CM383 (Biological)
CM383 intravenous infusion group
Experimental
干预措施: CM383 (Biological)
结局指标
主要结局
Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects
时间窗: Up to Day 85
Pharmacokinetic concentrations in serum and pharmacokinetic parameters: maximum concentration (Cmax).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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