NCT03330327已完成1 期
An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects
Hanmi Pharmaceutical Company Limited2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2015年3月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period
研究概览
简要总结
This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females must be non-pregnant and non-lactating
- •Males must be surgically sterile or using an acceptable contraceptive method
排除标准
- •Participation in an investigational study within 30 days prior to dosing
- •Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing
研究组 & 干预措施
Part 1
Experimental
Intravenous (IV) infusion of HM12470
干预措施: HM12470 (Biological)
Part 2: Sequence 1
Experimental
Intravenous (IV) infusion of HM12470
干预措施: HM12470 (Biological)
Part 2: Sequence 2
Experimental
Intravenous (IV) infusion of HM12470
干预措施: HM12470 (Biological)
结局指标
主要结局
Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period
时间窗: 1 month
- Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion
次要结局
- Cmax of HM12470(1 month)
- AUC of HM12470(1 month)
研究者
研究点 (2)
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