ACTRN12618000541202已完成1 期
A randomised, Phase 1, double-blind, placebo-controlled single and multiple ascending dose study to assess the safety, tolerability and pharmockinetics of PBT434 in healthy volunteers.
Alterity Therapeutics0 个研究点目标入组 82 人开始时间: 2018年4月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •SAD and MAD phases require healthy male and female adult volunteers aged between 18 and 55 (n=106 total in this age group).
- •One cohort of the MAD phase will be conducted in healthy elderly participants. The elderly cohort in MAD will be comprised of healthy male and female (not of childbearing potential) volunteers aged greater than or equal to 65 years (n=10 participants in this age group).
排除标准
- •History or presence of malignancy, clinically relevent medical illness, including cardiovascular, GI, hepatic, renal endocrine, neurologic and psychiatric, systemic allergic disease.
研究者
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