NCT04827472Unknown1 期
A Randomized, Double Blind, Placebo-controlled, Single Dose, Dose-escalation Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
研究概览
简要总结
The safety/tolerability and pharmacokinetic properties of DWJ1521 are evaluated after single intravenous administration of DWJ1521 in healthy adults.
The safety/tolerability and pharmacokinetic properties of DWJ1521 single intravenous administration and DWP14012 single oral administration in healthy adults are compared.
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
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 to 50 years old at the time of screening test
- •Those who weigh 55.0 kg or more and 90.0 kg or less at the time of the screening test and have a body mass index (BMI) of 18.0 or more and 28.0 or less ☞ BMI(kg/m2) = weight(kg) / {height(m)}2
排除标准
- •Clinically significant, liver, kidney, nervous system, immune system, respiratory system, endocrine system, etc., or blood or tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or have a history of character
- •Those with a history of gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetics evaluation of investigational drugs, and those with a history of gastrointestinal surgery (However, simple appendic surgery and hernia surgery are excluded)
- •Those who were tested positive for Helicobacter pylori
- •serologic test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) positive
- •Those whose blood AST and ALT exceeds 1.5 times the upper limit of the normal range in screening tests including additional tests.
研究组 & 干预措施
Part1(Cohort1) : DWJ1521 Amg
Experimental
干预措施: Normal saline (Drug)
Part1(Cohort1) : DWJ1521 Amg
Experimental
干预措施: DWJ1521 (Drug)
Part1(Cohort2) : DWJ1521 Bmg
Experimental
干预措施: Normal saline (Drug)
Part1(Cohort2) : DWJ1521 Bmg
Experimental
干预措施: DWJ1521 (Drug)
Part1(Cohort3) : DWJ1521 Cmg
Experimental
干预措施: Normal saline (Drug)
Part1(Cohort3) : DWJ1521 Cmg
Experimental
干预措施: DWJ1521 (Drug)
Part1(Cohort4) : DWJ1521 Dmg
Experimental
干预措施: Normal saline (Drug)
Part1(Cohort4) : DWJ1521 Dmg
Experimental
干预措施: DWJ1521 (Drug)
Part2 : DWJ1521 Xmg
Experimental
干预措施: DWJ1521 (Drug)
Part2 : DWP14012 Tablet
Experimental
干预措施: DWP14012 Tablet (Drug)
结局指标
主要结局
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
时间窗: [Time Frame: [Time Frame: 0 - 72 hours after dosing]]
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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