Prostate CancerPhase 1NCT06062355
Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer
A Phase 1 study testing HRS-9815 injection in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HRS-9815 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
- Conditions
- Prostate Cancer
- Being tested
- HRS-9815 injection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9815 injectionDrug
HRS-9815 injection
| Study group | Role | What they receive |
|---|---|---|
| HRS-9815 injection | Experimental | Not described Receives: Drug: HRS-9815 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs,
Measured: up to 30 days follow-up
Secondary outcomes (8)
Maximum plasma concentration (Cmax)
Measured: up to 1 days follow-up
time to maximum plasma concentration (Tmax)
Measured: up to 1 days follow-up
biological half-life (t1/2)
Measured: up to 1 days follow-up
cumulative urinary excretion rate based on radioactivity;
Measured: up to 1 days follow-up
Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
Measured: up to 1 days follow-up
Mean standardized uptake value (SUVmean)
Measured: up to 1 days follow-up
Maximum standardized uptake value (SUVmax),
Measured: up to 1 days follow-up
Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up]
Measured: up to 1 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062355
- Sponsor's protocol ID
- HRS-9815-101
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06062355
- Acronym / sponsor ID
- HRS-9815-101
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-9815 injection | Experimental | Drug: HRS-9815 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9815 injectionHRS-9815 injection | Drug | HRS-9815 injection |
Primary outcome
Incidence and severity of AEs and SAEs,
Time frame: up to 30 days follow-up
8 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: up to 1 days follow-up
time to maximum plasma concentration (Tmax)
Time frame: up to 1 days follow-up
biological half-life (t1/2)
Time frame: up to 1 days follow-up
cumulative urinary excretion rate based on radioactivity;
Time frame: 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
Mean standardized uptake value (SUVmean)
Time frame: up to 1 days follow-up
Maximum standardized uptake value (SUVmax),
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-9815 injection in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueying Xueying (+0518-82342973, xueying.zheng.xz17@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs, (time frame: up to 30 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.