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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-9815 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9815 injection | Drug | HRS-9815 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs and SAEs, | up to 30 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueying Xueying | Contact | +0518-82342973 | xueying.zheng.xz17@hengrui.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| Mean standardized uptake value (SUVmean) | 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |