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Trial Title:
Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer
NCT ID:
NCT06062355
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-9815 injection
Description:
HRS-9815 injection
Arm group label:
HRS-9815 injection
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary participation in this clinical trial, understanding of the study
procedures and being able to sign the informed consent form in writing;
2. Male, age ≥18 years;
3. ECOG score 0 - 1;
4. Histologically confirmed adenocarcinoma of the prostate;
Exclusion Criteria:
1. 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.
2. Active syphilis infection.
3. Known allergy, hypersensitivity, or contraindication to the trial product or any
component of its formulation.。
4. 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2023
Completion date:
December 2023
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06062355
