NCT07070349招募中1 期
A Phase I/II Clinical Study to Evaluate the Safety, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Efficacy of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Phase 1: Incidence of adverse events (AEs) of HRS-6213
研究概览
简要总结
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign the informed consent form; willing and able to follow the study protocol.
- •For healthy subjects：BMI 18~28kg/m2
- •For patients：
- •Patients with pathologically confirmed tumour
- •proposed surgical resection/exploration (including primary or recurrent metastatic tumour
- •sufficient organs function.
排除标准
- •Known severe allergic reactions, hypersensitivity or contraindications to the test drug or any component of its preparation, such as alcohol allergy or other allergic history that the investigator deems may increase the risk of the trial.
- •Received the following treatments before administration:
- •Received radionuclide diagnostic or therapeutic drugs before administration, and less than 10 physical half-lives have elapsed since the last administration.
- •Used any intravenous iodinated contrast agent within 24 hours before administration, or used any high-density oral contrast agent within 5 days before administration (oral water-based contrast agent is acceptable).
- •Concurrent infectious diseases
- •Severe urinary incontinence, hydronephrosis, severe micturition dysfunction.
- •Concurrent severe active infection requiring intravenous antibiotic treatment within 14 days before administration.
- •Unexplained fever > 38.5℃ lasting for more than 1 hour during screening or before administration.
- •Concurrent severe or poorly controlled cardiac diseases or symptoms, including but not limited to: NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 6 months before administration, QTcF > 450 msec in males or QTcF > 470 msec in females.
研究组 & 干预措施
HRS-6213
Experimental
干预措施: HRS-6213 (Drug)
结局指标
主要结局
Phase 1: Incidence of adverse events (AEs) of HRS-6213
时间窗: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the safety and tolerability of HRS-6213.
Phase 1: Radiation dosimetry
时间窗: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the distribution of radioactivity in tissues and organs, and obtain the accumulation in major organs, time-radioactivity curves, internal radiation absorbed doses of the whole body and major organs of HRS-6213
Phase 2: With reference to the Standard of Truth (SOT), evaluate the diagnostic efficacy indicators of HRS-6213 PET at the lesion level
时间窗: rom first dose of study drug to end of treatment (up to approximately 60 days)
evaluate the diagnostic efficacy indicators of HRS-6213.
次要结局
- Phase 1: Cmax(From first dose of study drug to end of treatment (up to approximately 7 days))
- Phase 1: Biological half-life (t½)(From first dose of study drug to end of treatment (up to approximately 7 days))
- Phase 1: Tmax(From first dose of study drug to end of treatment (up to approximately 7 days))
- Phase 1: urinary cumulative excretion rate(From first dose of study drug to end of treatment (up to approximately 7 days))
- Phase 1: Lesion uptake curve(From first dose of study drug to end of treatment (up to approximately 7 days))
- Phase 1: Image quality score(From first dose of study drug to end of treatment (up to approximately 7 days))
- Phase 2: The proportion of subjects with changes in disease staging and treatment decisions before and after HRS-6213 PET imaging.(From first dose of study drug to end of treatment (up to approximately 60 days))
- Phase 2: Intra-observer consistency of the diagnosticians' results(From first dose of study drug to end of treatment (up to approximately 7 days))
- Phase 2:Incidence of adverse events (AEs) of HRS-6213(From first dose of study drug to end of treatment (up to approximately 7 days))
研究者
研究点 (1)
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