A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hematology Parameters at Pre-specified Timepoints
研究概览
简要总结
This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese male or female who has agreed to sign and date the written informed consent form
- •Age 18-70 years
- •Body mass index (BMI) of 18-30 kg/m^2
- •General good state of health as judged by a qualified physician after completing physical examination
- •Fit, co-operative, and able to provide consent
排除标准
- •Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients
- •A history of motor disturbances
- •A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism
- •A history of drug, alcohol, or solvent abuse
- •The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening
- •Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening
- •Use of any medication (except paracetamol [acetaminophen] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit
- •Classification as a radiation worker
- •Women of child-bearing potential not accepting a highly effective method of birth control (A woman is considered of child-bearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause, in International Council on Harmonisation (ICH) M3 (R2); A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner, in ICH M3 (R2).
- •Pregnant or lactating women
研究组 & 干预措施
DaTSCAN™ ioflupane (123I) injection
Participants will receive a single intravenous (IV) injection of DaTSCAN™ ioflupane (123I) injection into an arm vein, followed by planar whole-body imaging at prespecified time points over a period of 48 hours after administration. Brain SPECT imaging will be acquired at 3 and 6 hours after administration.
干预措施: DaTSCAN™ Ioflupane (123I) Injection (Drug)
结局指标
主要结局
Change From Baseline in Hematology Parameters at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.
Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints
时间窗: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in thyroxine, free and triiodothyronine, free were reported.
Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints
时间窗: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in thyroxine and triiodothyronine were reported.
Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints
时间窗: Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in thyrotropin were reported.
Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints
时间窗: Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection
Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.
Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints
时间窗: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in heart rate were reported.
Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in hematocrit were reported.
Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale)
时间窗: 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection
Tolerability questionnaire evaluated participants mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep using 100 millimeter (mm) VAS. VAS is a continuous scale comprised of a horizontal line, usually 100 mm in length, where "0" stands for bad, and 100 mm stands for good. Higher score indicated better health outcomes.
Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in C reactive protein were reported.
Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in leukocytes, platelets timepoints were reported.
Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.
Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in amylase were reported.
Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints
时间窗: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in diastolic blood pressure were reported.
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints
时间窗: Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Physical examination included recording an assessment for the presence of abnormalities of the following: general appearance, skin, lungs, cardiovascular system, back and spine, abdomen, extremities, lymph nodes, and neurological exam. Clinical significance was determined by investigator.
Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in fibrinogen, hemoglobin were reported.
Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in albumin, protein were reported.
Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints
时间窗: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in systolic blood pressure were reported.
Number of Participants With Adverse Events (AEs)
时间窗: Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)
An AE was defined as any untoward medical occurrence in participants or clinical investigation participant which did not necessarily have to have been related to the investigational medical product (IMP). AEs were recorded from time of informed consent through the follow-up visit at 2 weeks (±2 days) after IMP administration.
Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in erythrocytes were reported.
Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints
时间窗: Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.
Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints
时间窗: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in temperature were reported.
Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints
时间窗: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in respiratory rate were reported.
Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints
时间窗: Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection
Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.
Change From Baseline in Oxygen Saturation at Pre-specified Timepoints
时间窗: Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)
Change from baseline in oxygen saturation were reported.
次要结局
- Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)(Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection)
- Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity(Up to 48 hours after DaTSCAN™ ioflupane (123I) injection)
- Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine(10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection)
- Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image(10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection)
- Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry(Up to 48 hours after DaTSCAN™ ioflupane (123I) injection)
- Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration(Up to 48 hours after DaTSCAN™ ioflupane (123I) injection)