Healthy Male Subjects, Suspected Prostate Cancer
Conditions
Brief summary
Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.
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.
Interventions
DRUGINR101
• 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT
Sponsors
Yunhe Pharmaceutical (Tianjin) Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase II primary outcome :diagnostic efficacy | 28 days after administration | The sensitivity, specificity, and accuracy of INR101 PET/CT |
| Phase I primary outcome: incidence of adverse events of INR101 injection | 7 days after administration | 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. |
| Phase I primary outcome:radiation dosimetry | 3 hours after administration | 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. |
| Phase I primary outcome:Tmax (Time to reach maximum plasma concentration) | 4 hours after administration | Assessment of INR101 Tmax in whole blood 4 hours after administration |
| Phase I primary outcome:t1/2 (Elimination half-life) | 4 hours after administration | Assessment of INR101 t1/2 in whole blood 4 hours after administration |
| Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t) | 4 hours after administration | Assessment of INR101 AUC0-t in whole blood 4 hours after administration |
| Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity) | 4 hours after administration | Assessment of INR101 AUC0-∞ in whole blood 4 hours after administration |
| Phase I primary outcome:CL (Clearance) | 4 hours after administration | Assessment of INR101 CL in whole blood 4 hours after administration |
| Phase I primary outcome:Cmax (Maximum plasma concentration) | 4 hours after administration | Assessment of INR101 Cmax in whole blood 4 hours after administration |
| Phase I primary outcome:SUV-standardized uptake value | 3 hours after administration | Assessment of INR101 uptake by PET scan by measuring standardized uptake value in the target organs. |
| Phase I primary outcome:%ID/g - percentage of injected dose per gram | 3 hours after administration | Assessment of INR101 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the target organs |
| Phase I primary outcome:residence time - residence time in the the target organs | 3 hours after administration | Assessment of INR101 uptake by PET scan by measuring residence time in the target organs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase II secondary outcome: Incidence of adverse events of INR101 injection | 7 days after administration | 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. |
Countries
China
Outcome results
None listed