NCT06549309尚未招募1 期
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants
Jemincare1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
- •Healthy adult males and/or females, 18 to 45 years of age;
- •Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg/m2) ,weight ≥45kg (female) or ≥50kg (male) .
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, or any other diseases judged by investigators that will be interference to the results of this study;
- •Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed;
- •Pregnant or lactating women;
- •Other conditions unsuitable for the trial judged by the investigators.
研究组 & 干预措施
Experimental
Active Comparator
JMKX003801
干预措施: JMKX003801 (Drug)
Placebo Comparator
Placebo Comparator
Normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: From baseline to Day 3
Incidence and features of AEs
次要结局
- Serum concentrations of JMKX003801(From baseline to Day 3)
研究者
研究点 (1)
Loading locations...
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