A Randomized, Double-blinded, Partial-open, Placebo/Active-controlled, Single/Multiple Dosing, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Characteristics of IY-828026 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
A randomized, double-blinded, partial-open, placebo/active-controlled, single/multiple dosing, dose escalation phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of IY-828026 in healthy adult volunteers
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 adult volunteers aged ≥ 19 and ≤ 50 years at screening
- •Body weight ≥ 50.0 kg to ≤ 90.0 kg and body mass index (BMI) of ≥ 18.5 kg/m2 to ≤ 29.9 kg/m2 at screening
- •Volunteers who were fully informed of and completely understood this study, voluntarily agreed to participate, and provided written consent to comply with the precautions
排除标准
- •Current or history of clinically significant disease of hepatobiliary (severe hepatic impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), nervous, immune, respiratory, gastrointestinal, endocrine, hemato-oncologic, cardiovascular (heart failure, torsades de pointes, etc.), urinary, or psychiatric (mood disorder, obsessive compulsory disorder, etc.) system or sexual dysfunctions
- •H. pylori eradication treatment within 6 months or positive result for H. pylori at screening
- •Hypersensitivity or history of clinically significant hypersensitivity to PPIs, P-CABs, and other drugs (aspirin, antibiotics, etc.)
- •A positive result in serology (hepatitis B tests, hepatitis C tests, human immunodeficiency virus [HIV] tests, or syphilis tests)
- •History of drug abuse or positive results for drug abuse in the urine drug screen
研究组 & 干预措施
(MAD) IY-828026 40 mg
Participants will receive oral administration of IY-828026 40 mg once daily for 7 days
干预措施: Placebo (Drug)
(MAD) IY-828026 20 mg
Participants will receive oral administration of IY-828026 20 mg once daily for 7 days
干预措施: IY-828026 (Drug)
(MAD) IY-828026 20 mg
Participants will receive oral administration of IY-828026 20 mg once daily for 7 days
干预措施: Placebo (Drug)
(MAD) IY-828026 40 mg
Participants will receive oral administration of IY-828026 40 mg once daily for 7 days
干预措施: IY-828026 (Drug)
(SAD) IY-828026 10 mg
Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator
干预措施: IY-828026 (Drug)
(SAD) IY-828026 10 mg
Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator
干预措施: Placebo (Drug)
(SAD) IY-828026 20 mg
Paritipants will receive single oral administration of IY-828026 20 mg or Placebo comparator
干预措施: IY-828026 (Drug)
(SAD) IY-828026 20 mg
Paritipants will receive single oral administration of IY-828026 20 mg or Placebo comparator
干预措施: Placebo (Drug)
(SAD) IY-828026 40 mg
Period 1: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fast) Period 2: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fed)
干预措施: IY-828026 (Drug)
(SAD) IY-828026 40 mg
Period 1: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fast) Period 2: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fed)
干预措施: Placebo (Drug)
(SAD) IY-828026 80 mg
Paritipants will receive single oral administration of IY-828026 80 mg or Placebo comparator
干预措施: IY-828026 (Drug)
(SAD) IY-828026 80 mg
Paritipants will receive single oral administration of IY-828026 80 mg or Placebo comparator
干预措施: Placebo (Drug)
(SAD) IY-828026 160 mg
Paritipants will receive single oral administration of IY-828026 160 mg or Placebo comparator
干预措施: IY-828026 (Drug)
(SAD) IY-828026 160 mg
Paritipants will receive single oral administration of IY-828026 160 mg or Placebo comparator
干预措施: Placebo (Drug)
(MAD) IY-828026 80 mg
Participants will receive oral administration of IY-828026 80 mg once daily for 7 days
干预措施: IY-828026 (Drug)
(MAD) IY-828026 80 mg
Participants will receive oral administration of IY-828026 80 mg once daily for 7 days
干预措施: Placebo (Drug)
(MAD) IY-828026A
Participants will receive oral administration of IY-828026A 40mg once daily for 7 days
干预措施: IY-828026A (Drug)
(MAD) IY-828026B
Participants will receive oral administration of IY-828026B 50mg once daily for 7 days
干预措施: IY-828026B (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Approximately Day 9 for SAD and Day 15 for MAD
All adverse events occurring during the clinical trial following a single or multiple ascending dose of IY-828026 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product. Events will be coded using MedDRA System Organ Class and Preferred Term. \[Unit of Measure\] Participants
Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose
Cmax will be determined using non-compartmental analysis following a single ascending dose of IY-828026 \[Unit of Measure\] ng/mL
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-last) (SAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose
AUC₀-t will be calculated using non-compartmental analysis following a single ascending dose of IY-828026 \[Unit of Measure\] ng·h/mL
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose
AUCinf will be calculated from the concentration-time curve following a single ascending dose of IY-828026 \[Unit of Measure\] ng·h/mL
Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose
Tmax will be derived from the plasma concentration-time profile following a single ascending dose of IY-828026
Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose
Terminal elimination half-life will be estimated from the terminal phase of the concentration-time curve following a single ascending dose of IY-828026 \[Unit of Measure\] Hour (h)
Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)
Cmax,ss will be measured at steady state during multiple ascending dosing (Day 1-7). \[Unit of Measure\] ng/mL
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)
AUCtau,ss will be calculated at steady state during multiple ascending dosing (Day 1-7) \[Unit of Measure\] ng·h/mL
Pharmacokinetic Parameters: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)
Tmax,ss will be derived from the plasma concentration-time profile at steady state during multiple ascending dosing (Day 1-7) \[Unit of Measure\] Hour (h)
Pharmacokinetic Parameters: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)
时间窗: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)
The terminal elimination half-life at steady state will be estimated from the terminal phase of the plasma concentration-time curve during multiple ascending dosing (Day 1-7) \[Unit of Measure\] Hour (h)
Pharmacodynamic Parameters: Gastric pH monitoring (SAD)
时间窗: Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour
Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration
Pharmacodynamic Parameters: Gastric pH monitoring (MAD)
时间窗: Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour, Day7 0hour to 24hour
Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (SAD)
时间窗: Day-1 0hour (relative to scheduled administration time on Day1, baseline), 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour post-dose
Maximum plasma gastrin concentration \[Unit of measure: ng/L\]
Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration (SAD)
时间窗: Day-1 0hour (relative to scheduled administration time on Day1, baseline), 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour post-dose
Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration \[Unit of measure: ng·h/L\]
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (MAD)
时间窗: Day-1 0hour, 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour, Day 4 0hour, Day 7 0hour, and 2, 4, 6, 8, 12, 24hour, 48hour, and 72hour
Maximum plasma gastrin concentration \[Unit of measure: ng/L\]
Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after multiple administration (MAD)
时间窗: Day-1 0hour, 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour, Day 4 0hour, Day 7 0hour, and 2, 4, 6, 8, 12, 24hour, 48hour, and 72hour
Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration \[Unit of measure: ng·h/L\]
次要结局
未报告次要终点