NCT00722540
已完成
1 期
Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.
概览
- 阶段
- 1 期
- 干预措施
- placebo
- 疾病 / 适应症
- Growth Hormone Disorder
- 发起方
- Novo Nordisk A/S
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability (adverse events, local tolerability, physical examination)
- 状态
- 已完成
- 最后更新
- 9年前
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.
研究者
入排标准
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
干预措施: placebo
A
干预措施: NNC126-0083
A
干预措施: placebo
B
干预措施: NNC126-0083
B
干预措施: placebo
C
干预措施: NNC126-0083
D
干预措施: NNC126-0083
D
干预措施: placebo
E
干预措施: NNC126-0083
E
干预措施: placebo
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))
研究点 (1)
Loading locations...
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