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.
1 other identifier
interventional
9
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 prostate-cancer
Started Oct 2023
Shorter than P25 for phase_1 prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 2, 2023
September 1, 2023
2 months
September 25, 2023
September 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and severity of AEs and SAEs,
up to 30 days follow-up
Secondary Outcomes (8)
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)
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
- +3 more secondary outcomes
Study Arms (1)
HRS-9815 injection
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2023
First Posted
October 2, 2023
Study Start
October 1, 2023
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
October 2, 2023
Record last verified: 2023-09