NCT06062355尚未招募1 期
Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Radiation Dosimetry of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 主要终点
- Incidence and severity of AEs and SAEs,
研究概览
简要总结
The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry of HRS-9815 for PET/CT imaging in adult patients with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
- •Male, age ≥18 years;
- •ECOG score 0 - 1;
- •Histologically confirmed adenocarcinoma of the prostate;
排除标准
- •Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
- •Active syphilis infection.
- •Known allergy, hypersensitivity, or contraindication to the trial product or any component of its formulation.。
- •Active in other clinical studies or less than 4 weeks after the last dose in the previous clinical study at the time of the first dose.
研究组 & 干预措施
HRS-9815 injection
Experimental
干预措施: HRS-9815 injection (Drug)
结局指标
主要结局
Incidence and severity of AEs and SAEs,
时间窗: up to 30 days follow-up
次要结局
- Mean standardized uptake value (SUVmean)(up to 1 days follow-up)
- cumulative urinary excretion rate based on radioactivity;(up to 1 days follow-up)
- Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;(up to 1 days follow-up)
- Maximum plasma concentration (Cmax)(up to 1 days follow-up)
- time to maximum plasma concentration (Tmax)(up to 1 days follow-up)
- biological half-life (t1/2)(up to 1 days follow-up)
- Maximum standardized uptake value (SUVmax),(up to 1 days follow-up)
- Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up](up to 1 days follow-up)
研究者
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