NCT00544934已完成1 期
A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Glycadia
- 入组人数
- 42
- 主要终点
- glycated albumimin concentration
研究概览
简要总结
A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent
排除标准
- •Sctive concomitant serious medical or surgical disease
研究组 & 干预措施
250 mg
Experimental
干预措施: GLY-230 (Drug)
500 mg
Experimental
干预措施: GLY-230 (Drug)
750 mg
Experimental
干预措施: GLY-230 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
glycated albumimin concentration
时间窗: three weeks
次要结局
- urine albumin(three weeks)
研究者
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