Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06062355
• Other study ID #: HRS-9815-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 2023
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Xueying Xueying
• Phone: +0518-82342973
• Email: xueying.zheng.xz17[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• HRS-9815 injection
HRS-9815 injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of AEs and SAEs,		up to 30 days follow-up
Secondary	Maximum plasma concentration (Cmax)		up to 1 days follow-up
Secondary	time to maximum plasma concentration (Tmax)		up to 1 days follow-up
Secondary	biological half-life (t1/2)		up to 1 days follow-up
Secondary	cumulative urinary excretion rate based on radioactivity;		up to 1 days follow-up
Secondary	Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;		up to 1 days follow-up
Secondary	Mean standardized uptake value (SUVmean)		up to 1 days follow-up
Secondary	Maximum standardized uptake value (SUVmax),		up to 1 days follow-up
Secondary	Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up]		up to 1 days follow-up