NCT01028521已完成1 期
Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
CellMed AG, a subsidiary of BTG plc.1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2010年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire)
研究概览
简要总结
A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of single ascending doses of CM3.1-AC100 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent prior to any study specific procedures
- •Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
- •Judged as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
排除标准
- •Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator
- •Blood donation within 3 month before administration of the IP
- •Have a history of hypersensitivity to the IP or any of the excipients or to medicinal products with similar chemical structures
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CM3.1-AC100
Experimental
干预措施: CM3.1-AC100 (Drug)
结局指标
主要结局
Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire)
时间窗: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
次要结局
未报告次要终点
研究者
研究点 (1)
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