NCT01515592已完成1 期
A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese 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
- 24
- 试验地点
- 1
- 主要终点
- Antibody against liraglutide
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Healthy Japanese subjects
- •BMI (Body Mass Index) between 18.0-27.0 kg/m^2 inclusive
排除标准
- •Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening
- •Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- •Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
- •History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- •History of significant allergy or hypersensitivity
- •Known or suspected allergy to trial product or related products
- •History of drug or alcohol abuse
- •The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure
研究组 & 干预措施
15 mcg/kg
Experimental
干预措施: liraglutide (Drug)
15 mcg/kg
Experimental
干预措施: placebo (Drug)
20 mcg/kg
Experimental
干预措施: liraglutide (Drug)
20 mcg/kg
Experimental
干预措施: placebo (Drug)
25 mcg/kg
Experimental
干预措施: liraglutide (Drug)
25 mcg/kg
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Antibody against liraglutide
Adverse events
Body weight
次要结局
- t½, terminal elimination half-life
- Cmax, maximum concentration
- tmax, time to reach Cmax
- 24-hour profiles of plasma glucose
- Area under the plasma liraglutide concentration curve
- Terminal elimination rate constant
- 24-hour profiles of serum insulin
研究者
研究点 (1)
Loading locations...
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