NCT06736587招募中1 期
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP212525 in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.2 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2024年12月10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
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Concentration of DWP212525 and metabolite M16
研究概览
简要总结
The safety and tolerability of single and multiple administration of DWP212525
详细描述
The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19 to 55 years
- •Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
- •Received a sufficient explanation on this study
- •Eligible as subjects in the study
排除标准
- •History of diseases such as clinically significant disease of hepatobiliary
- •Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
- •Hemato-oncologic diseases, including malignant tumor diagnosis
- •Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test
研究组 & 干预措施
Cohort8
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort4
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort1
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort2
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort3
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort5
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort6
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort7
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort9
Experimental
干预措施: DWP212525 placebo (Drug)
Cohort10
Experimental
干预措施: DWP212525 placebo (Drug)
结局指标
主要结局
Concentration of DWP212525 and metabolite M16
时间窗: Day 1 0 hour (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, and 72hours post-dose
Vz/F
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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