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

Phase 1

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: HRS-9815 injection

• Registration Number: NCT06062355
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Study Start: 2023-10
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-9815 injection	HRS-9815 injection	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of AEs and SAEs,	up to 30 days follow-up

Secondary Outcome Measures

Name	Time	Method
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