A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Apparent terminal phase half-life (T1/2) of LP-128
研究概览
简要总结
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects
详细描述
This trial includes single dose and multiple dose phases. The single-dose phase included six dose cohorts. Based on the safety and pharmacokinetic results of single-dose study, approximately 2 doses will be selected to conduct multiple-dose study. The primary study objectives are to evaluate the safety, tolerability, and pharmacokinetic characteristics of LP-128 capsules in healthy subjects after single and multiple dosing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 and fully understand the content, process and possible adverse reactions of the trial
排除标准
- •Abnormal vital signs, physical examination or laboratory tests with clinical significance
- •Abnormal ECG, chest X-ray, abdominal ultrasound or echocardiography with clinical significance
- •Positive screening for viral hepatitis, HIV and syphilis
- •Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug; or 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 major 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
- •Subjects who are not suitable for this trial based on the assessment of investigator
研究组 & 干预措施
Multi-dose Experimental Group
LP-128 capsule will be adminstrated once daily, for up to 14 days
干预措施: LP-128 capsules (Drug)
Single-dose Experimental Group
LP-128 capsule will be adminstrated one time at doses up to 240mg
干预措施: LP-128 capsules (Drug)
Single-dose Control Group
Placebo capsule will be adminstrated one time at doses up to 240mg
干预措施: Matching Placebo (Other)
Multi-dose Control Group
Placebo capsule will be adminstrated once daily, for up to 14 days
干预措施: Matching Placebo (Other)
结局指标
主要结局
Apparent terminal phase half-life (T1/2) of LP-128
时间窗: Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Plasma samples were collected at different points for pharmacokinetic analysis
Adverse events of LP-128
时间窗: Up to 28 days
The incidence and severity of adverse events as assessed by NCI CTCAE v5.0.
Maximum observed plasma concentration (Cmax) of LP-128
时间窗: Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Plasma samples were collected at different points for pharmacokinetic analysis
Area under the plasma concentration-time curve (AUC) of LP-128
时间窗: Up to 4 and 17 days in Single-dose group and Multi-dose group, respectively
Plasma samples were collected at different points for pharmacokinetic analysis
次要结局
- Excretion of LP-128 in urine(Up to 4 days)
- Excretion of LP-128 in feces(Up to 4 days)