NCT05703282已完成1 期
A Parallel, Open-Label, Single-Dose Administration, Phase 1 Clinical Study to Assess the Safety and Pharmacokinetics of AD-104-A in Healthy Adult Volunteers and Patients With Renal Impairment
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-104-A
详细描述
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-104-A in Healthy Adult Volunteers and Patients with Renal Impairment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all subjects
- •Adults aged 19 years and older
- •Body mass index(BMI) of 18 to 30 kg/m2
- •Voluntarily given written informed consent
- •For renal Impairment subjects
- •30 ≤ eGFR < 90 mL/min/1.73m^2
- •For healthy subjects
- •eGFR ≥ 90 mL/min/1.73m^2
排除标准
- •Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- •Other exclusions applied
研究组 & 干预措施
Renal Impairment 1
Experimental
Test Drug: AD-104-A
干预措施: AD-104-A (Drug)
Renal Impairment 2
Experimental
Test Drug: AD-104-A
干预措施: AD-104-A (Drug)
Renal Impairment 3
Experimental
Test Drug: AD-104-A
干预措施: AD-104-A (Drug)
Normal
Experimental
Test Drug: AD-104-A
干预措施: AD-104-A (Drug)
结局指标
主要结局
Cmax
时间窗: pre-dose to 192 hours
To assess the Cmax of AD-104-A
AUC
时间窗: pre-dose to 192 hours
To assess the AUC of AD-104-A
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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