Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472531
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-20
Brief Title:
A Study of PETCT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
Sponsor:
Yunhe Pharmaceutical Tianjin Co Ltd
Organization:
Yunhe Pharmaceutical Tianjin Co Ltd
Study Overview
Official Title:
A Phase IIIa Study of PETCT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III study in the management of Healthy Male Subjects and patients with suspected prostate cancer
Detailed Description:
A multi-center prospective open-label randomized Phase III 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 PETCT 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 PETCT at different dosages and imaging intervals using prostate biopsy pathology results as the reference standard
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 PETCT 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 PETCT at different dosages and imaging intervals using prostate biopsy pathology results as the reference standard
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None