jRCT2031250621招募中不适用
Healthy Japanese and Caucasian adults, and Japanese patients with IgA nephropathy Phase I Trial of AK1960
未提供0 个研究点目标入组 139 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 139
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
- Randomized
入排标准
- 年龄范围
- 18age old over 至 65age old not（—）
- 性别
- All
入选标准
- •Healthy volunteer part
- •Who are able to fully understand the contents of the clinical trial and are capable of providing written consent.
- •Healthy men and women (women who are not capable of becoming pregnant)
- •Who do not have the 430C>T mutation and the 1075A>C mutation in the CYP2C9 gene
- •Patients part
- •Who are able to fully understand the contents of the clinical trial and are capable of providing written consent.
- •Patients diagnosed with primary IgA nephropathy
- •Who do not have the 430C>T mutation and the 1075A>C mutation in the CYP2C9 gene
排除标准
- •Healthy volunteer part
- •Subjects with clinical abnormalities in laboratory tests, vital signs, or fixed 12-lead electrocardiogram (ECG)
- •Subjects under 50.0 kg in men, less than 45.0 kg in women
- •Subjects with a BM of 1 (Japanese men: less than 18.5 kg/m2 or greater than 25.0 kg/m2; Japanese women: less than 17.5 kg/m2 or greater than 25.0 kg/m2; Caucasian: less than 18.5 kg/m2 or greater than 30.0 kg/m2)
- •Patients part
- •Patients with IgA vasculitis or secondary IgA nephropathy
研究者
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