A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and PKs/PDs of YH4808 After Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808
研究概览
简要总结
First in human study
详细描述
Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.
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
- 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
- 是
入选标准
- •Healthy male volunteers in the age between 20 to 45 years old
- •Subjects who were determined to be appropriate through screening
- •Weight: over 50kg, within ±20% of ideal body weight
- •Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug
排除标准
- •Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
- •Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
- •A history of hypersensitivity to drugs or clinically significant allergic disease
- •Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
- •Subjects who were unable to be applicable for pH meter catheter
- •Subjects who had a history of drug abuse or who had a positive results on urine drug screening
- •Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
- •Subjects who participated in another clinical trial within 3 months before enrolling in this study
- •Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
- •Subjects who drank Over 21 units/week of alcohol or subjects who weren't able to stop drinking alcohol during the hospitalization
- •Subjects who stopped smoking within 3 months before the treatment
- •Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
- •Subjects who had a beverage containing caffeine during the hospitalization
- •H.pylori positive results on the Urease breath test(Only repeat doses)
- •Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators
研究组 & 干预措施
YH4808 30mg
1.Single dose
2.12 volunteers were administered YH4808 30mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 30mg (Drug)
YH4808 50mg
1.Single dose
2.12 volunteers were administered YH4808 50mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 50mg (Drug)
YH4808 400mg(repeat doses)
1.Repeat dose
2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 400 mg (repeat doses) (Drug)
YH4808 100mg
1.Single dose
2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 100mg (Drug)
YH4808 200mg
1.Single dose
2.12 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 200mg (Drug)
YH4808 400mg
1.Single dose
2.12 volunteers were administered YH4808 400mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 (Drug)
YH4808 600mg
1.Single dose
2.12 volunteers were administered YH4808 600mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 600mg (Drug)
YH4808 800mg
1.Single dose
2.12 volunteers were administered YH4808 800mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 800mg (single dose) (Drug)
YH4808 100mg(repeat doses)
1.Repeat doses
2.12 volunteers were administered YH4808 100mg or active/placebo comparators.(YH4808:active:placebo=8:2:2)
干预措施: YH4808 100mg (repeat dose) (Drug)
YH4808 200mg(repeat doses)
1.Repeat doses
2.16 volunteers were administered YH4808 200mg or active/placebo comparators.(YH4808:active:placebo=8:6:2)
干预措施: YH4808 200mg (repeat dose) (Drug)
Placebo
干预措施: Placebo (Drug)
Esomeprazole 40mg
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
To evaluate the PKs, PDs, safety and tolerability of escalating, single/multiple oral doses of YH4808
时间窗: Throughout the study
次要结局
未报告次要终点