A Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of XTR003 in Healthy Chinese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate the safety of healthy Chinese adults after a single dose of XTR003 intravenous injection. On Day1 of the study all subjects received a single dose 8.0-10 mCi of XTR003 intravenously.
研究概览
简要总结
18F-FDG PET imaging is now considered the most effective method used in the clinical evaluation of viable myocardium. However, the need for fasting or glucose and insulin loading in the 18F-FDG PET protocol makes it unfavorable for a certain group of patients (i.e., insulin-resistance and diabetic patients). XTR003 is a fatty acid analog used for PET imaging, developed at the Beijing Anzhen Hospital affiliated to Sinotau Pharmaceutical Group. XTR003 is a promising fatty acid analog and perhaps have a potential clinical utility in the evaluation of viable myocardium. This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of XTR003 in 10 Chinese normal healthy volunteers both male and female between the ages of 18-40.
详细描述
XTR003 is a PET imaging radiopharmaceutical agent used to trace myocardial fatty acid metabolism. XTR003 is a modified fatty acid that enters the myocytes and passes through mitochondrial membrane by the same process as the natural existing fatty acids and then undergoes partial β-oxidation before being trapped in the mitochondria. In preclinical study XTR003 showed high myocardial uptake and retention [1].
This is a phase I study, the study will be open-label, nonrandomised, single-arm, single-center clinical study. Subjects will receive single dose of XTR003.
Safety, biodistribution, radiation dosimetry and Pharmacokinetics was investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18-40 years
- •Normal electrocardiogram and echocardiography
- •Normal vital signs and physical examination
- •No any major illness
- •No clinically significant abnormalities in laboratory tests
- •No clinically significant anomalies in 12-lead ECG
- •Females of child bearing possibility should adopt effective medically approved contraceptive methods to prevent pregnancy for at least 6 months before the study and after the study
- •Voluntarily signed written consent from all subjects
排除标准
- •Pregnancy or lactating woman
- •History of cardiovascular disease
- •History of any brain disease
- •History of coagulopathy
- •History of liver or gastrointestinal diseases or other factors that can interfere with drug absorption, distribution, excretion or metabolism
- •Past history of cancer
- •History of drug allergy
- •History of drug abuse or alcohol dependance
- •Any medications and treatments that may interfere with the test data or may cause serious side effects
- •Human immunodeficiency virus (HIV), hepatitis C or syphilis antibody test positive, hepatitis B surface antigen positive
- •Exposure to significant occupational radiation (e.g >50 mvs/year) or exposure radioactive substances for therapeutic or research purposes over the past 10 years
- •Use of health products or medications (eg. coenzyme Q10, etc.) that have an effect on myocardial energy metabolism within 1 week
- •Hospital admission due to illness during the screening period
研究组 & 干预措施
XTR003
Administration and investigation of myocardial fatty acid radiotracer
干预措施: XTR003 (Drug)
结局指标
主要结局
To evaluate the safety of healthy Chinese adults after a single dose of XTR003 intravenous injection. On Day1 of the study all subjects received a single dose 8.0-10 mCi of XTR003 intravenously.
时间窗: 0 to 14 days post injection
All subjects returned to the hospital on Day 2 and Day 7 after XTR003 injection for safety observation that included: Physical examination, vital signs monitoring, blood troponin-I levels, routine blood test, blood biochemistry test, routine urine test, and 12-lead electrocardiogram. On Day 14 all subjects were telephoned for the final follow-up. All adverse events after enrolment in the study will be documented.
次要结局
- To investigate the biodistribution of XTR003(0 to 5 hours)