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临床试验/NCT00722540
NCT00722540
已完成
1 期

Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.

Novo Nordisk A/S1 个研究点 分布在 1 个国家目标入组 40 人2008年7月

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.

注册库
clinicaltrials.gov
开始日期
2008年7月
结束日期
2009年4月
最后更新
9年前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

责任方
Sponsor

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)

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