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

September 25, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-9815 injection
Drug: HRS-9815 injection
HRS-9815 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of AEs and SAEs,
Time Frame: up to 30 days follow-up
up to 30 days follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-9815-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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