NCT02151409已完成1 期
A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to develop a complement system targeted monoclonal antibody (mAb) to be used in treatment of subjects with chronic autoimmune diseases.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
- •Body weight (BW) below or equal to 110.0 kg
- •Body Mass Index (BMI) 20.0 - 27.0 kg/m^2, both inclusive
- •Good state of health: evidenced by medical history, physical examination and results of laboratory examinations
排除标准
- •History of known or suspected cardiovascular diseases including: supine systolic blood pressure (BP) above or equal to 140 mmHg or below 90 mm Hg, diastolic BP above oe equal to 90 mm Hg or below 40 mm Hg, heart rate (HR) in supine position above 100 beats/minute or below 45 beats/minute
- •Hepatic insufficiency: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above Upper Limit of Normal (ULN) (retesting is permitted within one week if first test is elevated but below 1.5 fold ULN)
- •Renal insufficiency: Serum creatinine above ULN
- •Positive for humane immunodeficiency virus (HIV) (by test)
- •Positive for hepatitis B (HBV) or hepatitis C (HCV) (by test)
研究组 & 干预措施
NNC 0151-0000-0000 i.v.
Experimental
Dose escalation trial
干预措施: NNC 0151-0000-0000 (Drug)
NNC 0151-0000-0000 s.c.
Experimental
Dose escalation trial
干预措施: NNC 0151-0000-0000 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Week 0-10
次要结局
未报告次要终点
研究者
研究点 (1)
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