A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LP-168 Following Single and Multiple Oral Administration to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
研究概览
简要总结
This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.
详细描述
This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10 subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of 8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose phase.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer
- •Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
- •Male and female healthy subjects aged 18 to 55 years old
- •Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
- •Subjects able to understand and comply with study requirements
- •Willing to sign the informed consent
排除标准
- •Abnormal vital signs, physical examination or laboratory tests with clinical significance
- •Abnormal ECG or echocardiography with clinical significance
- •Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
- •Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
- •Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
- •Subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
- •Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
- •Female subjects are breastfeeding or pregnant
- •Subjects who have a history of drug/ alcohol/ tobacco abuse
- •Subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening
- •Subjects who have participated in other clinical trial within three months before screening
- •Subjects have special dietary requirements or cannot tolerate a standard meal
研究组 & 干预措施
LP-168 tablet
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
干预措施: LP-168 tablet (Drug)
LP-168 Placebo tablet
After confirmation of inclusion, subjects will be randomized into the LP-168 tablet or LP-168 placebo tablet arm and receive single or multiple doses of LP-168 tablet or LP-168 placebo tablet.
干预措施: LP-168 Placebo tablet (Drug)
结局指标
主要结局
Severity of Treatment Emergent Adverse Events as determined by CTCAE v5.0
时间窗: From the first dose of the study drug to 5 days after last dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) of LP-168
时间窗: Up to 96 hours post last dose
PK As Assessed By Terminal Vd/F of LP-168
时间窗: Up to 96 hours post last dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) of LP-168
时间窗: Up to 96 hours post last dose
PK As Assessed By Terminal Half-life (t1/2) of LP-168
时间窗: Up to 96 hours post last dose
PK As Assessed By Terminal CL/F of LP-168
时间窗: Up to 96 hours post last dose
Number of Participants With Treatment Emergent Adverse Events as determined by CTCAE v5.0
时间窗: From the first dose of the study drug to 5 days after last dose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time of The Last Quantifiable Concentration (AUC0-t) Of LP-168
时间窗: Up to 96 hours post last dose
次要结局
- PD as Assessed by elisa analysis the proportion of LP-168 occupied kinase at scheduled timepoints pre-dose and post-dose(Up to 48 hours post last dose)