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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06062355
Collaborator
(none)
9
Enrollment
1
Arm
2
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: HRS-9815 injection
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HRS-9815 injection

Drug: HRS-9815 injection
HRS-9815 injection

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of AEs and SAEs, [up to 30 days follow-up]

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax) [up to 1 days follow-up]

  2. time to maximum plasma concentration (Tmax) [up to 1 days follow-up]

  3. biological half-life (t1/2) [up to 1 days follow-up]

  4. cumulative urinary excretion rate based on radioactivity; [up to 1 days follow-up]

  5. Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs; [up to 1 days follow-up]

  6. Mean standardized uptake value (SUVmean) [up to 1 days follow-up]

  7. Maximum standardized uptake value (SUVmax), [up to 1 days follow-up]

  8. Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up] [up to 1 days follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT06062355
Other Study ID Numbers:
  • HRS-9815-101
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 2, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Oct 2, 2023