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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-9815 injection

Group Type EXPERIMENTAL

HRS-9815 injection

Intervention Type DRUG

HRS-9815 injection

Interventions

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HRS-9815 injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No