NCT03399214已完成1 期
A Phase Ib Study to Evaluate Safety and Efficacy Profiles of IOP Injection for Magnetic Resonance Imaging (MRI) Contrast Agent in Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Change of MRI SI (%) in vessels, liver, and spleen
研究概览
简要总结
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
详细描述
Find the max. signal change after IOP administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, age ≥ 20 ~40 years, BMI=18~
- •The biochemistry test results, complete blood count (CBC) test results, urinalysis test results, coagulation time test results must within normal range or considered clinically normal by the clinical investigator at screening.
- •Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days.
- •No screening of drug or alcohol abuse within one year prior to study enrollment.
- •Subjects are willing to comply with the protocol and sign informed consent form.
排除标准
- •Subjects have serious allergic history or known allergy to MRI contrast agent.
- •Subjects with HBV, HCV, HIV.
- •Imaging and/or functional abnormalities of liver and/or spleen.
- •Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
- •Subjects have electronically, magnetically and mechanically activated implanted devices.
- •Subjects have participated in other investigational trials or receive any contrast agents within 28 days prior to study enrollment.
- •Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption and elimination of investigational contrast agent.
- •Subjects have taken any food 6 hours prior to administration.
研究组 & 干预措施
IOP Injection, Phase 1b, Cohort 1
Experimental
IV injection, 0.27 mg/kg
干预措施: IOP Injection (Drug)
IOP Injection, Phase 1b, Cohort 2
Experimental
IV injection, 0.54 mg/kg
干预措施: IOP Injection (Drug)
结局指标
主要结局
The Change of MRI SI (%) in vessels, liver, and spleen
时间窗: Day1: within 60 mins after IOP administration
The optimal imaging time of IOP injection for the maximum SI (%)
次要结局
- The changes from baseline in hematology data(within 14 days)
- The incidence of all treatment-related adverse events (TRAE)(within 14 days)
研究者
研究点 (1)
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