A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
NCT Number: NCT06472531
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Healthy Male Subjects|Suspected Prostate Cancer
Interventions: DRUG: INR101|DRUG: INR101
Sponsor: Yunhe Pharmaceutical (Tianjin) Co., Ltd
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-05-23
Completion Date: 2025-05-30
Locations: Yunhe Pharmaceutical (Tianjin) Co., Ltd., Tianjin, Tianjin, 100088, China

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

Primary Outcome Measures: 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 Outcome Measures: 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., 7 days after administration