Status:
UNKNOWN
Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06062355
Start Date
October 1 2023
End Date
December 1 2023
Last Update
October 2 2023
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