NCT00722540已完成1 期
Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese 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
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability (adverse events, local tolerability, physical examination)
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects with Japanese passport and Japanese born parents
- •Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
- •Subjects must be in good health according to age
排除标准
- •A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
- •History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
- •Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator
研究组 & 干预措施
C
Experimental
干预措施: placebo (Drug)
A
Experimental
干预措施: NNC126-0083 (Drug)
A
Experimental
干预措施: placebo (Drug)
B
Experimental
干预措施: NNC126-0083 (Drug)
B
Experimental
干预措施: placebo (Drug)
C
Experimental
干预措施: NNC126-0083 (Drug)
D
Experimental
干预措施: NNC126-0083 (Drug)
D
Experimental
干预措施: placebo (Drug)
E
Experimental
干预措施: NNC126-0083 (Drug)
E
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability (adverse events, local tolerability, physical examination)
时间窗: 0 to 10 days after third dosing, (day 15-25 after first dose)
次要结局
- Cmax, maximum concentration of IGF-I(7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose))
研究者
研究点 (1)
Loading locations...
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