NOX-E36 - A Phase Ib, Multiple Intravenous Dose Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties in Healthy Subjects and Then in Three Groups of Patients With Type 2 Diabetes Mellitus to Compare Three Ascending Dose Regimens in a Double-blind and Placebo-controlled Manner
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 5
- 主要终点
- Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus
研究概览
简要总结
The primary objective of this trial is to evaluate the safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus. A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic response at the level of inflammation, metabolism as well as ongoing diabetes complications (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to provide sufficient safety and dose-response data for a planned Phase IIa proof of concept study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Group A: Healthy male and female subjects
- •Group B-D: Patients with type 2 diabetes mellitus according to ADA definition; GFR > 60 mL/min; HbA1c ≥ 6.0 and ≤9.0 %; normoalbuminuria, microalbuminuria or macroalbuminuria
排除标准
- •History of or presence of clinically significant diseases with the exception of diabetes (Groups B-D)
- •Concurrent illness that may affect blood glucose other than diabetes
- •Supine blood pressure at screening, after resting for 5 min, of >140 mmHg systolic or > 90 mmHg diastolic (Group A) or > 160 mmHg systolic or > 95 mmHg in diabetes mellitus patients (Groups B-D)
- •Clinically significant abnormal ECG at screening
- •Any kidney disease not caused by diabetes or hypertension
- •Type 1 diabetes mellitus
研究组 & 干预措施
Group A
干预措施: NOX-E36 (Drug)
Group B - D
干预措施: NOX-E36 (Drug)
结局指标
主要结局
Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus
时间窗: 4 weeks
次要结局
- Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus(4 weeks)