A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA
研究概览
简要总结
A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •Male and females 21-65 years.
- •Clinically acceptable medical history
排除标准
- •Healthy Volunteers
- •Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months.
- •Suffers from claustrophobia.
- •Bilateral hip prostheses.
- •Key Inclusion Criteria: Patients
- •Male 18-80 years.
- •Histologically confirmed adenocarcinoma of the prostate
- •Clinically acceptable medical history
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Key Exclusion Criteria: Patients
- •Biopsy 28 days prior to enrollment.
- •Extensive metastatic disease.
- •Underlying disease which might confound interpretation.
- •Bilateral hip prostheses.
- •High energy (>300 Kiloelectron Volt (keV)) gamma-emitting radioisotope administered within five physical half-lives, or any intravenous iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug administration.
- •X-ray contrast agent (<24 hr for intravenous agents and <5 days for oral agents).
- •History of claustrophobia.
研究组 & 干预措施
Healthy Volunteers
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
干预措施: rhPSMA-7.3 (18F) Injection (Drug)
Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
干预措施: rhPSMA-7.3 (18F) Injection (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA
时间窗: 1 month
Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period, and changes in serum biochemistry, hematology, coagulation, urinalysis, vital signs, Electrocardiogram (ECG), injection site status, and physical examination findings.
次要结局
未报告次要终点