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The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-6213 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6213 | Drug | HRS-6213 IV administered as imaging agent for PET scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Incidence of adverse events (AEs) of HRS-6213 | To evaluate the safety and tolerability of HRS-6213. | From first dose of study drug to end of treatment (up to approximately 7 days) |
| Phase 1: Radiation dosimetry | 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 | From first dose of study drug to end of treatment (up to approximately 7 days) |
| Phase 2: With reference to the Standard of Truth (SOT), evaluate the diagnostic efficacy indicators of HRS-6213 PET at the lesion level | evaluate the diagnostic efficacy indicators of HRS-6213. | rom first dose of study drug to end of treatment (up to approximately 60 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Cmax | To evaluate the PK of HRS-6213 | From first dose of study drug to end of treatment (up to approximately 7 days) |
| Phase 1: Biological half-life (t½) | To evaluate the PK of HRS-6213 |
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Inclusion Criteria:
Voluntarily sign the informed consent form; willing and able to follow the study protocol.
For healthy subjects:BMI 18~28kg/m2
For patients:
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Chen | Contact | 0518-82342973 | xiao.chen.xc1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| From first dose of study drug to end of treatment (up to approximately 7 days) |
| Phase 1: Tmax | To evaluate the PK of HRS-6213 | From first dose of study drug to end of treatment (up to approximately 7 days) |
| Phase 1: urinary cumulative excretion rate | To evaluate the PK of HRS-6213 | From first dose of study drug to end of treatment (up to approximately 7 days) |
| Phase 1: Lesion uptake curve | Lesion uptake curve of lesions detected by PET scans at different time points HRS-6213. | From first dose of study drug to end of treatment (up to approximately 7 days) |
| Phase 1: Image quality score | Imaging quality scores of HRS-6213 with Likert image quality rating scale and signal-to-noise ratio. | 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. | changes in disease staging and treatment decisions due to diagnostic test. | From first dose of study drug to end of treatment (up to approximately 60 days) |
| Phase 2: Intra-observer consistency of the diagnosticians' results | consistency of the diagnosticians' results by investigators. | 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 | To evaluate the safety and tolerability of HRS-6213. | From first dose of study drug to end of treatment (up to approximately 7 days) |