Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
研究概览
简要总结
Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects
详细描述
Pharmacokinetic (PK) parameters, Pharmacodynamics
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 or female subjects aged 18-45 years (inclusive);-
- •With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;
- •Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.
排除标准
- •Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial
- •Subjects with history of or current malignancy;
- •Participant who the researchers believe that there are volunteers who are not suitable for
研究组 & 干预措施
JMKX003002 SAD experimental group
Participants will be randomized into 5 cohorts to receive single oral dose of JMKX003002 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: JMKX003002 will be administered orally (Drug)
JMKX003002 MAD experimental group
Participants will be randomized into 2 cohorts to receive orally twice -daily of JMKX003002 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: JMKX003002 will be administered orally (Drug)
JMKX003002 FE experimental group
Participants will receive 3 Sequence regimens, with a washout period between treatments.
干预措施: JMKX003002 will be administered orally (Drug)
Placebo in Cohorts 1 to 5
Participants in Cohorts 1 to 5 will receive single oral dose of matching placebo on Day 1.
干预措施: Placebo in Cohorts 1 to 5 (Drug)
Placebo in 2 Cohorts
Participants in 2 Cohorts will receive orally twice -daily of matching placebo for 7 consecutive days.
干预措施: Placebo in 2 Cohorts (Drug)
结局指标
主要结局
Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
时间窗: from baseline to Day 18
multiple dose safety
Number of the Adverse Events that are related to the single dose treatment
时间窗: from baseline to Day 11
single dose safety
次要结局
未报告次要终点