A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YP05002 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)
研究概览
简要总结
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race.
- •In good health as determined by the Investigator, with no clinically significant findings from medical/psychiatric history, physical examination, 12-lead ECG, vital signs measurements, clinical laboratory evaluations.
排除标准
- •Have evidence of any clinically significant active or chronic disease.
- •Histories of using drug that affect drug absorption, distribution, metabolism, or excretion within 14 days or within 5-half-life prior to the first dose (whichever is longer); gastrointestinal disorders with impaired gastric emptying; or prolonged use of medications that directly modulate gastrointestinal motility.
- •Had clinically relevant acute or chronic medical conditions or diseases that would pose a risk to participant's safety or interfere with the study assessments, as determined by the Investigator.
- •Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.
- •Diagnosis of any type of pancreatitis.
研究组 & 干预措施
MAD Cohort 1
MAD dose 1
干预措施: Placebo (Other)
MAD Cohort 2
MAD dose 2
干预措施: YP05002 (Drug)
MAD Cohort 2
MAD dose 2
干预措施: Placebo (Other)
MAD Cohort 3
MAD dose 3
干预措施: YP05002 (Drug)
MAD Cohort 3
MAD dose 3
干预措施: Placebo (Other)
SAD Cohort 1
SAD dose 1
干预措施: YP05002 (Drug)
SAD Cohort 1
SAD dose 1
干预措施: Placebo (Other)
SAD Cohort 2
SAD dose 2
干预措施: YP05002 (Drug)
SAD Cohort 2
SAD dose 2
干预措施: Placebo (Other)
SAD Cohort 3
SAD dose 3
干预措施: YP05002 (Drug)
SAD Cohort 5
SAD dose 5
干预措施: Placebo (Other)
SAD Cohort 3
SAD dose 3
干预措施: Placebo (Other)
SAD Cohort 4
SAD dose 4
干预措施: YP05002 (Drug)
SAD Cohort 4
SAD dose 4
干预措施: Placebo (Other)
SAD Cohort 5
SAD dose 5
干预措施: YP05002 (Drug)
MAD Cohort 1
MAD dose 1
干预措施: YP05002 (Drug)
结局指标
主要结局
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)
时间窗: Up to Day 14
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD)
时间窗: Up to Day 41
次要结局
- Cmax of YP05002 (SAD)(Up to Day 14)
- Cmax of YP05002 (MAD)(Up to Day 41)