An Open-label, Single-center, Single-arm Phase I Clinical Trial Evaluating the Safety and Tolerability, Biodistribution and Radiation Dosimetry, and Pharmacokinetics of Flotufolastat F-18 Injection in Healthy Chinese Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults. (%ID)
研究概览
简要总结
Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). This phase I study investigated the safety, biodistribution, radiation dosimetry and Pharmacokinetics of Flotufolastat F-18 Injection in 6 healthy elderly Chinese volunteers.
详细描述
Flotufolastat F-18 Injection is a positron emission tomography (PET) imaging tracer that targets the extracellular domain of prostate-specific membrane antigen (PSMA). It is intended for the detection of prostate cancer (PCa) lesions.This Phase I study will be open-labeled, nonrandomized, single center study. Enrolled 6 healthy Chinese volunteers who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 5.47~6.69mCi of Flotufolastat F-18 Injection via IV injection. Safety and tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have the ability to understand the content of study and voluntarily sign the informed consent form.
- •Healthy male or female, aged 18-60 (included).
- •Body mass index (BMI) between 19 and 26 kg/m² (included).
- •Vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray (posterior-anterior view), and abdominal ultrasound are normal, or any abnormalities that are diagnosed clinically insignificant.
- •Clinical laboratory test results are within normal ranges or any abnormalities that are diagnosed clinically insignificant.
- •Have the ability to communicate effectively with the investigator and comply with the study requirement to follow-up.
- •Female subject shouldcontracept effectively during the study period and 6 months after the study completed (effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy). Male subject should agree to use contraception during the study period and 6 months after the study completed.
排除标准
- •Claustrophobia or inability to tolerate imaging examinations for any other reason.
- •Have a history of epilepsy or seizures, excluding childhood febrile seizures.
- •With chronic diseases, including but not limited to:
- •cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof.
- •history of psychiatric disorders or currently significant psychiatric conditions
- •Have a history of asthma or allergies.
- •Have a history of malignant tumors.
- •Present any condition that may interfere with the absorption or metabolism of the investigational drug, or that may affect study results, as determined by the investigator to be clinically significant.
- •Underwent any surgical procedure within 3 months before administration or planned surgery during the study period.
- •Accomplished the blood donation or significant blood loss (>400 mL) within 3 months before administration or during the screening period.
- •Insufficient venous access (two distinct venous lines are required for investigational drug administration and PK sampling).
- •Known allergy to the active ingredient or any excipients of the investigational product.
- •Took any medications, including prescription, over-the-counter drugs, or herbal remedies, within 14 days before administration.
- •Participated any other new drug's clinical trial within 4 weeks prior to the administration or within 5 half-lives of the investigating drug (whichever is longer).
- •Radiopharmaceutical imaging or treatment within 7 days prior to screening or within 5 half-lives of the radiopharmaceutical (whichever is longer).
- •Pregnant or breastfeeding women.
- •Abnormal serological results (hepatitis B surface antigen, syphilis treponemal antibody, human immunodeficiency virus antibody, hepatitis C antibody) diagnosed clinically significant by the investigator.
- •QTc intervalis longer than 450 milliseconds during the screening period.
- •Major occupational exposure to ionizing radiation in the past 10 years (e.g., more than 50 mSv/year) or exposure to radioactive materials or ionizing radiation for therapeutic or research purposes.
- •Any reason determined by the investigator that could not complet the study.
研究组 & 干预措施
Flotufolastat F-18 Injection
Single dose 5.47~6.69mCi mCi intravenous injection of Flotufolastat F-18 Injection
干预措施: Flotufolastat F-18 Injection (Drug)
结局指标
主要结局
To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults. (%ID)
时间窗: Day 1
Radioactive accumulation (%ID) in target organs following administration of Flotufolastat F-18 Injection.
To evaluate the biodistribution of Flotufolastat F-18 Injection after a single bolus intravenous injection in healthy Chinese adults.
时间窗: Day 1
Standardized uptake value (SUV) in target organs following administration of Flotufolastat F-18 Injection.
次要结局
- To assess the radiation dosimetry of Flotufolastat F-18 Injection(Day 1)
- To evaluate the pharmacokinetic of Flotufolastat F-18 Injection(Day 1)
- Proportions of radioactive parent compound in plasma(Day 1)
- To evaluate the safety profile of Flotufolastat F-18 Injection(Day 2)