NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment
研究概览
简要总结
This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.
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
- Double (Participant, Investigator)
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
- •Healthy male and female subjects
- •Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
- •Body weight between 50 and 100 kg inclusive
- •Creatinine clearance of greater than 80 mL/min
排除标准
- •Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
- •Intake of any prescribed systemic or topical medication within 14 days prior to dosing
- •Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
- •Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
- •History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders
研究组 & 干预措施
2.0 mg/kg i.v.
干预措施: NOX-E36 (Drug)
Placebo s.c.
干预措施: Placebo (Drug)
0.25 mg/kg s.c.
干预措施: NOX-E36 (Drug)
0.5 mg/kg i.v.
干预措施: NOX-E36 (Drug)
1.0 mg/kg i.v.
干预措施: NOX-E36 (Drug)
Placebo i.v.
干预措施: Placebo (Drug)
0.03 mg/kg i.v.
干预措施: NOX-E36 (Drug)
0.09 mg/kg i.v.
干预措施: NOX-E36 (Drug)
0.25 mg/kg i.v.
干预措施: NOX-E36 (Drug)
0.5 mg/kg s.c.
干预措施: NOX-E36 (Drug)
结局指标
主要结局
Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment
时间窗: throughout the entire study
次要结局
- Pharmacokinetic parameters in plasma and urine(throughout the entire study)
- Pharmacodynamic profile(throughout the entire study)