NCT01165502已完成1 期
Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple 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 40 人开始时间: 2010年7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
- 40
- 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 Intensity, anti- CM3.1-AC100 antibodies)
研究概览
简要总结
The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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;
- •Male volunteer aged 18 to 50 years at Screening, both inclusive;
- •Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
排除标准
- •Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;
- •Blood donation within 3 month before administration of the IP;
- •Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
研究组 & 干预措施
CM3.1-AC100
Experimental
Compound CM3.1-AC100 s.c.
干预措施: CM3.1-AC100 (Drug)
Placebo
Placebo Comparator
Placebo for compound CM3.1-AC100 s.c.
干预措施: Placebo (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 Intensity, anti- CM3.1-AC100 antibodies)
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
- Pharmacokinetic samples for CM3.1-AC100(Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7)
研究者
研究点 (1)
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