A Single-Blind Placebo-Controlled Dose Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of Cor-1, An Anti-ß1 Receptor Antibody Cyclopeptide, in Five Different Strengths in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Number of Participants Reporting Adverse Events (AEs)
研究概览
简要总结
Primary Trial objectives:
To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose level, 10 subjects receiving placebo)
Secondary objectives:
To evaluate safety and tolerability by using adverse events (AEs) and vital signs
详细描述
Primary Trial objective:
To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in healthy, male volunteers after single intravenous administration
Secondary objectives:
To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, male Caucasians between 18 and 45 years of age, inclusive
- •Normotensive subjects (systolic BP <140 mmHg and diastolic BP <90 mmHg)
- •Body mass index (BMI) 19-27, minimal weight 60 kg
- •Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests, and negative result in anti-ß1-receptor-autoantibody screening
- •Signed Informed Consent Form
- •Normal or clinically irrelevant laboratory findings
排除标准
- •Autoimmune disorders
- •Kidney diseases
- •Liver diseases, liver function impairments
研究组 & 干预措施
COR-1
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
干预措施: COR-1 (Drug)
placebo
intravenous 0.9 % NaCl
干预措施: placebo (Drug)
结局指标
主要结局
The Number of Participants Reporting Adverse Events (AEs)
时间窗: 45 days
To assess the safety and tolerability of COR-1.
次要结局
未报告次要终点