NCT00964262已完成1 期
A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of SR Exenatide (PT302) After Subcutaneous Injection in Healthy Male Volunteers
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
- 34
- 试验地点
- 1
- 主要终点
- To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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 aged 20-45 years at screening
- •Body weight over 50 kg, inclusive, and within 20% of ideal body weight
排除标准
- •Has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
- •Has a sign or symptom or history related to an acute or chronic pancreatitis
- •Has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
- •Has ever been exposed to exenatide
- •Shows SBP >= 150 mmHg or <= 90 mmHg or DBP >= 100 mmHg or <= 50 mmHg
- •Has a presence or history of drug abuse
- •Uses any prescription drug, herbal medicine within 2 weeks or OTC drugs or vitamin within 1 week prior to study drug administration
- •Has been participated in other clinical trial within 2 months
- •Has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
- •Heavy smoker more than 10 cigarettes/day within 3 months prior to screening
- •Continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
- •Subjects not eligible at the discretion of investigators
研究组 & 干预措施
SR Exenatide (PT302)
Experimental
Intervention: Drug: SR Exenatide (PT302)
干预措施: SR Exenatide (PT302) (Drug)
SR Exenatide (PT302)
Experimental
Intervention: Drug: SR Exenatide (PT302)
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
时间窗: 8 weeks
次要结局
- To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection(8 weeks)
研究者
研究点 (1)
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