Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
研究概览
简要总结
A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers
详细描述
To evaluate the safety, tolerability, and pharmacokinetic characteristics and to explore pharmacodynamic characteristics and food effects after single and multiple doses of ID120040002 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
- 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
- •Subjects who have a body weight of ≥50.0 kg to ≤90.0 kg, and Body Mass Index (BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2
- •Subjects who have decided to voluntarily participate and consented in writing to comply with the precautions after listening to a detailed explanation of this clinical study
- •Subjects who consent to use contraceptive methods* accepted in this trial with their partners and not to donate sperm until 90 days and eggs until 28 days after the administration of the last dose of the IP from the time of written consent.
排除标准
- •Subjects with a history of clinically significant cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, urinary, musculoskeletal and psychological disorders or malignant tumor, or current active diseases (however, subjects may be enrolled if the disease is completely recovered and does not affect the current health status)
- •Subjects with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, hypochlorhydria, achlorhydria, etc.) or gastrointestinal surgery (excluding simple appendectomy and herniotomy) that can affect the absorption of the investigational product
- •Subjects who have received the therapy for peptic ulcer, esophageal disease or Zollinger-Ellison syndrome within 90 days prior to the administration of the IP, or have clinically suspected symptoms of such diseases
- •Subjects who have received H. pylori eradication therapy within 6 months, or have positive result for H. pylori test at screening
研究组 & 干预措施
ID120040002 Fmg
Multiple dose 10 volunteers will be administered ID120040004 F mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: Placebo comparator (Drug)
ID120040002 Gmg
Multiple dose 10 volunteers will be administered ID120040004 G mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: ID120040002 (Drug)
ID120040002 A mg
Single dose 8 volunteers will be administered ID120040002 Amg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: ID120040002 (Drug)
ID120040002 A mg
Single dose 8 volunteers will be administered ID120040002 Amg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: Placebo comparator (Drug)
ID120040002 Bmg
Single dose 8 volunteers will be administered ID120040002 Bmg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: ID120040002 (Drug)
ID120040002 Bmg
Single dose 8 volunteers will be administered ID120040002 Bmg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: Placebo comparator (Drug)
ID120040002 Cmg
Single dose 8 volunteers will be administered ID120040002 Cmg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: ID120040002 (Drug)
ID120040002 Cmg
Single dose 8 volunteers will be administered ID120040002 Cmg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: Placebo comparator (Drug)
ID120040002 Dmg
Period1:
Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2)
Period2:
Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: ID120040002 (Drug)
ID120040002 Dmg
Period1:
Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2)
Period2:
Single dose 8 volunteers will be administered ID120040002 Dmg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: Placebo comparator (Drug)
ID120040002 Emg
Single dose 8 volunteers will be administered ID120040002 Emg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: ID120040002 (Drug)
ID120040002 Emg
Single dose 8 volunteers will be administered ID120040002 Emg or placebo comparators (ID120040002: placebo = 6:2)
干预措施: Placebo comparator (Drug)
ID120040002 Fmg
Multiple dose 10 volunteers will be administered ID120040004 F mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: ID120040002 (Drug)
ID120040002 Gmg
Multiple dose 10 volunteers will be administered ID120040004 G mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: Placebo comparator (Drug)
ID120040002 Hmg
Multiple dose 10 volunteers will be administered ID120040004 H mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: ID120040002 (Drug)
ID120040002 Hmg
Multiple dose 10 volunteers will be administered ID120040004 H mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: Placebo comparator (Drug)
ID120040002 Img
Multiple dose 10 volunteers will be administered ID120040004 I mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: ID120040002 (Drug)
ID120040002 Img
Multiple dose 10 volunteers will be administered ID120040004 I mg or placebo comparators (ID120040002: placebo: 8:2)
干预措施: Placebo comparator (Drug)
Compound-X Jmg
Multiple dose 8 volunteers will be administered compound-X J mg
干预措施: Compound-X (Drug)
结局指标
主要结局
Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
时间窗: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
Number of participants with Serious Adverse Events (SAEs)
时间窗: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Number of participants with Adverse Events (AEs)
时间窗: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
To evaluate the safety and tolerability of single and multiple ascending doses of ID120040002 in healthy participants.
Percentage of subjects with clinically significant change from baseline in vital signs
时间窗: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 14 for MAD)
次要结局
未报告次要终点