NCT06472531

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Yunhe Pharmaceutical (Tianjin) Co., Ltd · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Subjects
• Suspected Prostate Cancer

Interventions

Type	Name	Description
DRUG	INR101	• 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT
DRUG	INR101	* 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

Timeline

• Start date: 2024-05-23
• Primary completion: 2024-09-30
• Completion: 2024-10-10
• First posted: 2024-06-25
• Last updated: 2024-10-30

Locations

1 site across 1 country: China