search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HRS-9815 injection
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HRS-9815 injection

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence and severity of AEs and SAEs,

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 25, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06062355
    Brief Title
    Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HRS-9815 injection
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    HRS-9815 injection
    Intervention Description
    HRS-9815 injection
    Primary Outcome Measure Information:
    Title
    Incidence and severity of AEs and SAEs,
    Time Frame
    up to 30 days follow-up
    Secondary Outcome Measure Information:
    Title
    Maximum plasma concentration (Cmax)
    Time Frame
    up to 1 days follow-up
    Title
    time to maximum plasma concentration (Tmax)
    Time Frame
    up to 1 days follow-up
    Title
    biological half-life (t1/2)
    Time Frame
    up to 1 days follow-up
    Title
    cumulative urinary excretion rate based on radioactivity;
    Time Frame
    up to 1 days follow-up
    Title
    Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
    Time Frame
    up to 1 days follow-up
    Title
    Mean standardized uptake value (SUVmean)
    Time Frame
    up to 1 days follow-up
    Title
    Maximum standardized uptake value (SUVmax),
    Time Frame
    up to 1 days follow-up
    Title
    Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up]
    Time Frame
    up to 1 days follow-up

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xueying Xueying
    Phone
    +0518-82342973
    Email
    xueying.zheng.xz17@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs