Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Radiation Dosimetry of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer.

Jiangsu HengRui Medicine Co., Ltd.0 sites9 target enrollmentOctober 2023

ConditionsProstate Cancer

InterventionsHRS-9815 injection

Overview

Phase: Phase 1
Intervention: HRS-9815 injection
Conditions: Prostate Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 9
Primary Endpoint: Incidence and severity of AEs and SAEs,
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2023

End Date

December 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Arms & Interventions

HRS-9815 injection

Intervention: HRS-9815 injection

Outcomes

Primary Outcomes

Incidence and severity of AEs and SAEs,

Time Frame: up to 30 days follow-up

Secondary Outcomes

Mean standardized uptake value (SUVmean)(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)
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)
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)