NCT01034202已完成1 期
A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male 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
- 56
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking male subjects
- •Body Mass Index (BMI) between 19.0 and 28.0 kg/m2, both inclusive
- •Body weight max. 100 kg
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
- •Carrier of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies
- •Positive result of test for HIV (Human Immunodeficiency Virus) antibodies
- •Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the physician
- •Clinically significant abnormal ECG (ElectroCardioGram) at screening as evaluated by the physician
- •A significant history of alcoholism or drug/chemical abuse, or who has a positive result in the urine drug/alcohol screen, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits)
- •Habitual smoking, i.e daily smoking or more than 7 cigarettes/week
- •Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of their general practitioner or the Investigator should not participate in the trial
- •Surgery or trauma with significant blood loss within the last 2 months prior to dosing
研究组 & 干预措施
Norditropin® SimpleXx® 0.02 mg/kg + placebo
Placebo Comparator
干预措施: placebo (Drug)
Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083
Experimental
干预措施: NNC126-0083 (Drug)
Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083
Experimental
干预措施: Norditropin® SimpleXx® (Drug)
Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083
Experimental
干预措施: NNC126-0083 (Drug)
Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083
Experimental
干预措施: Norditropin® SimpleXx® (Drug)
Norditropin® SimpleXx® 0.02 mg/kg + placebo
Placebo Comparator
干预措施: Norditropin® SimpleXx® (Drug)
Norditropin® SimpleXx® 0.04 mg/kg + placebo
Placebo Comparator
干预措施: placebo (Drug)
Norditropin® SimpleXx® 0.04 mg/kg + placebo
Placebo Comparator
干预措施: Norditropin® SimpleXx® (Drug)
NNC126-0083
Experimental
干预措施: NNC126-0083 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of adverse events
时间窗: after administration of a single dose of NNC126-0083
次要结局
- Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083(0-168 hours after trial drug administration)
- Number of injection site reactions(after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx®)
- IGF-I (Insulin-like Growth Factor I) levels(after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx®)
研究者
研究点 (1)
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