NCT06344533尚未招募1 期
Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
Jemincare1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年4月10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
- 78
- 试验地点
- 1
- 主要终点
- Number of the Adverse Events that are related to the multiple dose treatment
研究概览
简要总结
To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects
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 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 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 Injection
Experimental
Single and multiple doses of JMKX003142 Injection administered intravenously.
干预措施: JMKX003142 Injection (Drug)
Placebo
Placebo Comparator
Placebo administered intravenously.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of the Adverse Events that are related to the multiple dose treatment
时间窗: From Baseline to Day12
multiple dose safety multiple dose safety
Number of the Adverse Events that are related to the single dose treatment
时间窗: From Baseline to Day7
single dose safety single dose safety
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Trial of JMKX003801 in Healthy ParticipantsHealthyNCT06549309Jemincare70
招募中
1 期
Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy SubjectsSafety and TolerabilityNCT05907382Jemincare80
已完成
2 期
A Dose-finding Study of JMKX003142 in Treatment of Renal EdemaNCT06670534Jemincare133
招募中
2 期
JMKX000189 for Moderate to Severe Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicNCT05967520Jemincare48
终止
1 期
A Phase 1 Study of XL019 in Adults With Polycythemia VeraPolycythemia VeraNCT00595829Exelixis3