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Healthy Male SubjectsPhase 1/2NCT06472531

A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

A Phase 1/2 study testing INR101 in people with Healthy Male Subjects and Suspected Prostate Cancer, run by Yunhe Pharmaceutical (Tianjin) Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
What is being tested?
INR101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
23 May 2024to 10 Oct 2024
Phase
Phase 1/2
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
  • Healthy volunteers accepted
  • Adult, Older adult

Phase 1 Inclusion Criteria:

  1. Males aged ≥18 years old
  2. Good health status or no major illness, judged by the investigator based on the following assessments: medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests that are normal or abnormal but not clinically significant
  3. Agree to use contraceptive measures from the day of signing the informed consent form until 3 months after drug administration, to avoid sperm donation;
  4. The subjects/legally authorized representative/guardian understands the purpose and procedures of the trial, and signs the informed consent form.

Phase 2 Inclusion Criteria:

  1. Males aged ≥18 years
  2. ECOG score of 0 or 1
  3. Subjects who are planned to undergo prostate biopsy for pathological examination after clinical assessment, with no contraindications for biopsy
  4. Routine blood tests, liver and kidney function, and coagulation function meet the corresponding conditions
  5. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, to avoid sperm donation
  6. The subject/legal authorized representative/guardian understands the purpose and procedures of the trial and signs the informed consent form

Phase 1 Exclusion Criteria:

  1. Subjects who cannot complete INR101 imaging according to the requirements
  2. Subjects who cannot complete pharmacokinetics sample collection according to the requirements
  3. Serum virology examination (Heptitis B surface antigen,Anti-Treponema pallidum antibody,HIV antibodies,Antibody to Hepatitis C Virus) is abnormal, which is judged by the researchers to have clinical significance
  4. History of mental illness
  5. History of past malignant tumors
  6. History of past heart-related diseases
  7. History of significant brain diseases in the past
  8. Suffering from severe and/or poorly controlled and/or unstable diseases that the researcher judges may affect the study
  9. History of bleeding or coagulation disorders
  10. History of alcohol abuse or drug abuse/dependency
  11. Known allergy to the active ingredients of INR101 or its components
  12. Participated in other clinical trials before screening or during screening, or plans to participate in other clinical trials during this study
  13. The researcher judges that there are any medical diseases or other conditions that may affect safety, compliance or may affect the results of the study

Phase 2 Exclusion Criteria:

  1. Subjects who are unable to complete the INR101 imaging as required
  2. History of any other malignant tumors in the past
  3. Subjects in other interventional clinical trials or subjects in clinical trials of radioactive therapeutic drugs before signing the informed consent form
  4. Receiving any anti-tumor treatment before drug administration
  5. Known allergy to the active ingredients of INR101 or its components Abnormal serum virology examination
  6. Researchers judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Yunhe Pharmaceutical (Tianjin) Co., Ltd.

    Tianjin, Tianjin Municipality, 100088

Other trials in China

About this study

Official title: A Phase I/IIa Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.

Read the detailed description

A multi-center, prospective, open-label, randomized Phase I/II diagnostic study designed for the management of healthy male subjects and patients with suspected prostate cancer.

Phase I Study Objective: The primary goal is to assess the biodistribution, dosimetry, pharmacokinetic (PK) attributes, and safety profile of INR101 injections in healthy Chinese male subjects. The specific endpoints include evaluating the safety, Standardized Uptake Value (SUV), Accumulation (%ID), Retention Time, Absorbed Dose, Effective Dose, and PK parameters in whole blood, plasma, and urine following an intravenous administration of INR101.

Phase II Study Objective: This phase aims to determine the diagnostic efficacy of INR101 injection PET/CT scans in patients with suspected prostate cancers. The principal aim is to ascertain the optimal imaging conditions, which involve determining the best dose and timing of administration. This will be gauged based on the diagnostic performance metrics-sensitivity, specificity, and accuracy-of the INR101 injection PET/CT at different dosages and imaging intervals, using prostate biopsy pathology results as the reference standard.

Being tested
INR101

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INR101Drug

    Also called INR101 PET CT

    • 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT

  • INR101Drug

    Also called INR101 PET CT

    • 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT
    • 7±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT
Study groups in NCT06472531
Study groupRoleWhat they receive
phase IExperimentalExperimental: INR101 PET/ CT Drug: INR101.
Receives: Drug: INR101
phase IIExperimentalExperimental: INR101 PET/ CT Interventions: Drug: INR101
Receives: Drug: INR101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I primary outcome: incidence of adverse events of INR101 injection

    Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 7 days after administration

  2. Phase I primary outcome:radiation dosimetry

    Mean absorbed radiation doses were estimated using the source and target organ framework. Eight health subjects underwent serial INR 101 PET/CT scans at three time points following radiotracer injection: 5±5 min，30±5 min，60±10 min，120±10 min，180±20 min.

    Measured: 3 hours after administration

  3. Phase I primary outcome:Tmax (Time to reach maximum plasma concentration)

    Assessment of INR101 Tmax in whole blood 4 hours after administration

    Measured: 4 hours after administration

  4. Phase I primary outcome:t1/2 (Elimination half-life)

    Assessment of INR101 t1/2 in whole blood 4 hours after administration

    Measured: 4 hours after administration

  5. Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t)

    Assessment of INR101 AUC0-t in whole blood 4 hours after administration

    Measured: 4 hours after administration

  6. Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity)

    Assessment of INR101 AUC0-∞ in whole blood 4 hours after administration

    Measured: 4 hours after administration

  7. Phase I primary outcome:CL (Clearance)

    Assessment of INR101 CL in whole blood 4 hours after administration

    Measured: 4 hours after administration

  8. Phase I primary outcome:Cmax (Maximum plasma concentration)

    Assessment of INR101 Cmax in whole blood 4 hours after administration

    Measured: 4 hours after administration

  9. Phase I primary outcome:SUV-standardized uptake value

    Assessment of INR101 uptake by PET scan by measuring standardized uptake value in the target organs.

    Measured: 3 hours after administration

  10. Phase I primary outcome:%ID/g - percentage of injected dose per gram

    Assessment of INR101 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the target organs

    Measured: 3 hours after administration

  11. Phase I primary outcome:residence time - residence time in the the target organs

    Assessment of INR101 uptake by PET scan by measuring residence time in the target organs

    Measured: 3 hours after administration

  12. Phase II primary outcome :diagnostic efficacy

    The sensitivity, specificity, and accuracy of INR101 PET/CT

    Measured: 28 days after administration

Secondary outcomes (1)

  1. Phase II secondary outcome: Incidence of adverse events of INR101 injection

    Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 7 days after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start23 May 2024
  3. Primary completion30 Sep 2024
  4. Study completion10 Oct 2024

Resources

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 1/2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06472531
Sponsor's protocol ID
INR101-I/IIa-01
Status last verified
May 2024
First submitted
20 May 2024
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INR101 in people with Healthy Male Subjects and Suspected Prostate Cancer, run by Yunhe Pharmaceutical (Tianjin) Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I primary outcome: incidence of adverse events of INR101 injection (time frame: 7 days after administration). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06472531.

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 30 Oct 2024.

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