Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Tablets Administered Randomly, Double-blind, Placebo-controlled Single and Multiple Times in Healthy Adult Subjects, as Well as the Effects of Randomized, Open, and Two Cycle Crossover Foods
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Number of the Adverse Events that are related to the single dose treatment
研究概览
简要总结
Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of JMKX003142 tablets administered randomly, double-blind, placebo-controlled single and multiple times in healthy adult subjects, as well as the effects of randomized, open, and two cycle crossover foods
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 18-45 years (including boundary values)
- •Able to sign a written informed consent form
- •Physical examination, clinical laboratory examination value, Virology examination, vital signs and 12 lead ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
- •The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol
排除标准
- •Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
- •Participants in any other clinical study within 3 months prior to the first administration of this study
- •The investigators believe that the subject has other factors that are not suitable for participating in this experiment
- •Pregnant or lactating women
研究组 & 干预措施
JMKX003142 SAD experimental group
Participants will be randomized into 7 cohorts to receive single oral dose of JMKX003142 on Day 1. The doses in each cohort will be escalated based on the safety and pharmacokinetics (PK) / Pharmacodynamics (PD) data of the previous cohort.
干预措施: JMKX003142 will be administered orally (Drug)
JMKX003142 MAD experimental group
Participants will be randomized into 3 cohorts to receive orally once -daily of JMKX003142 for 7 consecutive days. The second cohort will be escalated based on the safety and pharmacokinetics (PK)/ Pharmacodynamics (PD) data of the previous cohort.
干预措施: JMKX003142 will be administered orally (Drug)
JMKX003142 FE experimental group
Participants will receive 2 Sequence regimens, with a washout period between treatments.
干预措施: JMKX003142 will be administered orally (Drug)
Placebo in Cohorts 1 to 7
Participants in Cohorts 1 to 7 will receive single oral dose of matching placebo on Day 1.
干预措施: Placebo in Cohorts 1 to 7 (Drug)
Placebo in 3 Cohorts
Participants in 3 Cohorts will receive orally once -daily of matching placebo for 7 consecutive days.
干预措施: Placebo in 3 Cohorts (Drug)
结局指标
主要结局
Number of the Adverse Events that are related to the single dose treatment
时间窗: from baseline to Day 18
single dose safety
Number of the Adverse Events that are related to the multiple dose treatment from
时间窗: from baseline to Day 24
multiple dose safety
次要结局
未报告次要终点