NCT04159961已完成1 期
A Randomized, Open-label, Parallel Design Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic of DWJ211 in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年12月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult aged between 19 and 65 at screening
- •Those whose BMI is less than 40kg/m2
- •Subject who will agree with the no treatment(liposuction or surgery, obesity treatment)
- •Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
排除标准
- •Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- •History of any intervention to treat Submental fat or abdominal fat
- •History or current symptoms of dysphagia
- •History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment
研究组 & 干预措施
GroupA
Experimental
Inject the Drug into submental fat and abdominal fat via subcutaneous
干预措施: DWJ211 (Drug)
GroupB
Experimental
Inject the Drug into submental fat and abdominal fat via subcutaneous
干预措施: DWJ211 (Drug)
GroupC
Experimental
Inject the Drug into submental fat and abdominal fat via subcutaneous
干预措施: DWJ211 (Drug)
结局指标
主要结局
Cmax
时间窗: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Maximum concentration of DWJ211
Tmax
时间窗: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Time of maximum concentration
AUCt
时间窗: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Area under the drug concentration-time curve
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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