NCT07301502尚未招募1 期
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease
Akeso1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease.
详细描述
This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease. Subjects will be randomized to receive AK152 regimen or placebo treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AK152 regimen
Active Comparator
干预措施: AK152 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Events (AE)
时间窗: Up to approximately 8 weeks after the last dose
The incidence of AEs.
次要结局
- Peak concentration (Cmax)(Up to approximately 8 weeks after the last dose)
- Time to peak (Tmax)(Up to approximately 8 weeks after the last dose)
- Area under the curve (AUC)(Up to approximately 8 weeks after the last dose)
- Half-life (t1/2)(Up to approximately 8 weeks after the last dose)
- Immunogenicity characteristics of AK152(Up to approximately 8 weeks after the last dose)
研究者
研究点 (1)
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