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

NCT06472531 | Completed Phase 1

• 1 other identifier: INR101-I/IIa-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Subjects; Suspected Prostate Cancer

Outcome Measures

Primary Outcomes (12)

• 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.

  7 days after administration

• 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.

  3 hours after administration

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

  Assessment of INR101 Tmax in whole blood 4 hours after administration

  4 hours after administration

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

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

  4 hours after administration

• 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

  4 hours after administration

• 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

  4 hours after administration

• Phase I primary outcome:CL (Clearance)

  Assessment of INR101 CL in whole blood 4 hours after administration

  4 hours after administration

• Phase I primary outcome:Cmax (Maximum plasma concentration)

  Assessment of INR101 Cmax in whole blood 4 hours after administration

  4 hours after administration

• Phase I primary outcome:SUV-standardized uptake value

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

  3 hours after administration

• 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

  3 hours after administration

• 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

  3 hours after administration

• Phase II primary outcome :diagnostic efficacy

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

  28 days after administration

Secondary Outcomes (1)

• Phase II secondary outcome: Incidence of adverse events of INR101 injection

  7 days after administration

Study Arms (2)

phase I

EXPERIMENTAL

Experimental: INR101 PET/ CT Drug: INR101.

Drug: INR101

phase II

EXPERIMENTAL

Experimental: INR101 PET/ CT Interventions: Drug: INR101

Drug: INR101

Interventions

INR101 DRUG

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

Also known as: INR101 PET CT

phase I

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who cannot complete INR101 imaging according to the requirements
• Subjects who cannot complete pharmacokinetics sample collection according to the requirements
• 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
• History of mental illness
• History of past malignant tumors
• History of past heart-related diseases
• History of significant brain diseases in the past
• Suffering from severe and/or poorly controlled and/or unstable diseases that the researcher judges may affect the study
• History of bleeding or coagulation disorders
• History of alcohol abuse or drug abuse/dependency
• Known allergy to the active ingredients of INR101 or its components
• Participated in other clinical trials before screening or during screening, or plans to participate in other clinical trials during this study
• 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
• Subjects who are unable to complete the INR101 imaging as required
• History of any other malignant tumors in the past

Sponsors & Collaborators

• Yunhe Pharmaceutical (Tianjin) Co., Ltd: lead

Study Sites (1)

Yunhe Pharmaceutical (Tianjin) Co., Ltd.

Tianjin, Tianjin Municipality, 100088, China

Location

Study Officials

• Jinming Zhang, Ph.D

  The First Medical Center of the General Hospital of the Chinese People's Liberation Army

  PRINCIPAL INVESTIGATOR

• Jigang Yang, Ph.D

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Fugeng Liu, BD

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

• Xuejuan Wang, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 25, 2024
• Study Start: May 23, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 10, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)