Clinical trial · Interventional
Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer
Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Radiation Dosimetry of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer.
NCT06062355CI-TRIAL-00070111unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-9815 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-9815 injection
- interventionNames
- Drug: HRS-9815 injection
Primary outcomes (1)
- measure
- Incidence and severity of AEs and SAEs,
- timeFrame
- up to 30 days follow-up
Secondary outcomes (8)
- measure
- Maximum plasma concentration (Cmax)
- timeFrame
- up to 1 days follow-up
- measure
- time to maximum plasma concentration (Tmax)
- timeFrame
- up to 1 days follow-up
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.