NCT03654313已完成1 期
A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability of MEDI6570
研究概览
简要总结
To evaluate the safety, tolerability, PK and immunogenicity of single and multiple ascending doses of MEDI6570 in subjects with Type 2 Diabetes Mellitus
详细描述
A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of MEDI6570 in Subjects with Type 2 Diabetes Mellitus
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability of MEDI6570
时间窗: Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B)
Measured by the incidence of treatment- emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
次要结局
- Immunogenicity rate(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
- Pharmacokinetics of MEDI6570 Tmax(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
- Pharmacokinetics of MEDI6570 AUC(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
- Pharmacokinetics of MEDI6570 Cmax(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
- Pharmacokinetics of MEDI6570 Terminal Half life(Day 1 - Day 190 (Part A); Day 1 - Day 250 (Part B))
研究者
研究点 (10)
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