An Open-label Phase I Clinical Trial to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of subjects reporting clinically significant changes in serum biochemical tests
研究概览
简要总结
This is a phase 1 study to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.
详细描述
Ga-68 is a positron-emitting radionuclide with short half-life of 68 minutes. Dolacga is a non-radiolabeled formulated drug product and will be reconstituted to become the finished radiopharmaceutical product Ga68-Dolacga Injection, a PET tracer specifically targeting to surface receptors of hepatocytes. The study aims to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Male or female subjects aged 20 or above, inclusive, at date of consent.
- •Body mass index (BMI) between 18.5 and 23.0, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2])
- •Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to use a barrier contraception method for the duration of the study.
- •Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration.
- •Male subjects must not donate sperm for the study duration.
- •Willing and able to cooperate with study procedures
- •Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and ECG
- •Laboratory values within reference range, unless values are deemed by the Principal Investigator as "Not Clinically Significant"
- •Negative result for hepatitis B and C antigen test
排除标准
- •Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of study product as stated in this protocol
- •Implantation of metal devices including cardiac pacemaker, intravascular metal devices
- •Current or prior history of major psychiatric disorders, epilepsy and major depression
- •History of positive test for human immunodeficiency virus (HIV)
- •History of chronic alcohol or drug abuse within the last 6 months
- •Pregnant women, lactating or breast-feeding women
- •Clinically significant abnormal laboratory values and/or clinically significant or unstable medical illness
- •General PET exclusion criteria
- •Prior participation in nuclear medicine treatments or computer tomography examinations in the last year
- •Subject has received an investigational drug or device within 30 days of screening.
- •Subjects having high risks for the study according to the PI discretion
- •Subjects who can't be followed up for any reason
研究组 & 干预措施
Ga68-Dolacga Injection
The healthy volunteer was injected with Ga68-Dolacga Injection iv and performed PET imaging for liver reserve evaluation.
干预措施: Ga68-Dolacga Injection (Drug)
结局指标
主要结局
Number of subjects reporting clinically significant changes in serum biochemical tests
时间窗: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in hematological tests
时间窗: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in urinalysis
时间窗: from pre-dose to 14±2 days post dose
Number of subjects with body temperature abnormalities
时间窗: from pre-dose to 14±2 days post dose
Abnormalities of physical examination in visit 2 (post-treatment) compared with visit 1
时间窗: visit 2 (Day 1)
Including the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 14 days
All laboratory abnormalities which are compared with screening values and out of the reference range will be considered as AE and will be assessed its relationship to the study drug. Any ECG changes including ECG waveform will be assessed as AE(s) and will be followed to assess whether they resolved and when they resolved.
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
时间窗: from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in Heart Rate
时间窗: from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in electrocardiogram(ECG)
时间窗: from pre-dose to 14±2 days post dose
The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)
次要结局
- Establishment of the normal reference range of the percent of injection dose (%ID) in healthy liver(up to 60 minutes after administration of Ga68-Dolacga Injection)