A Phase I Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 Administered Intravenously in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Vital signs
研究概览
简要总结
The objectives of this study are:
- To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
- To determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128 in normal healthy adult volunteers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •No significant medical history
- •Normal physical examination
- •No clinically significant abnormalities in baseline laboratory values
- •No clinically significant abnormalities on 12 lead electrocardiogram
- •Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening and pre-injection on dosing day
- •Written informed consent signed
排除标准
- •Pregnancy or lactation
- •Know hypersensitivity to the investigational drug or any of its components
- •Current enrolment in another investigational study
- •Unwillingness to provide or continue informed consent
研究组 & 干预措施
99mTc-rhAnnexin V-128
干预措施: Kit for the Preparation of 99mTc-rhAnnexin V-128 (Drug)
结局指标
主要结局
Vital signs
时间窗: At each study visit
Descriptive statistics of the vital signs (pulse rate and blood pressure) observed values as well as for the changes from baseline value will be created. Frequency tabulations with values within, below or above the normal ranges will be made.
Electrocardiography
时间窗: screening and immediatly, 24hrs, 72 hrs, 7 days and 30 days after injection
ECG parameters will include heart rate (HR), RR interval, PR interval, QRS width and QT interval. ECG results will be evaluated by means of descriptive statistics and frequency tabulations.
Laboratory assessments
时间窗: baseline and 24 hrs, 72 hrs and 30 days after injection
Laboratory data (Hematology, coagulation, biochemistry, and urinalysis) will be analysed with respect to the normal ranges of values provided by the local laboratory and with respect to pre-defined levels of change in these values. Abnormal laboratory test results will be tabulated.
Adverse events
时间窗: Whole study period
Type and incidence of AEs, as well as severity and relatedness to the study medication will be tabulated. Special attention will be given to those subjects who prematurely discontinue the study or the study medication due to an AE, or who experience a severe AE or an SAE.
次要结局
- Blood sample counting(baseline and 0, 5,10, 15, 30, 60, 90 min, 3 h, 6 h and 24 hours post-injection)
- Amount of 99mTc excreted in faeces(Baseline and within 24h post injection)
- Anti-rhAnnexin V-128 IgG and IgM antibodies(Baseline and 14 and 30 days post-injection)
- rhAnnexin V-128 serum concentration(0, 5, 10, 15, 30, 60, 90, minutes and 3 h, 6h and 24 h post-injection)
- Whole-body SPECT imaging(30min, 90min, 3hrs, 6hrs and 24 hours post-injection)
- Amount of 99mTc excreted in urine(One sample at baseline and urine collection within 24 hours post-injection)