Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Location contact
Jihui Hao
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07070349
The study is being conducted to evaluate the safety, radiation dosimetry, pharmacokinetics, and preliminary diagnostic efficacy of HRS-6213.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Jihui Hao
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS-6213 IV administered as imaging agent for PET scan.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the safety and tolerability of HRS-6213.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the distribution of radioactivity in tissues and organs, and obtain the accumulation in major organs, time-radioactivity curves, internal radiation absorbed doses of the whole body and major organs of HRS-6213
Time frame: rom first dose of study drug to end of treatment (up to approximately 60 days)
evaluate the diagnostic efficacy indicators of HRS-6213.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the PK of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the PK of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the PK of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the PK of HRS-6213
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Lesion uptake curve of lesions detected by PET scans at different time points HRS-6213.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
Imaging quality scores of HRS-6213 with Likert image quality rating scale and signal-to-noise ratio.
Time frame: From first dose of study drug to end of treatment (up to approximately 60 days)
changes in disease staging and treatment decisions due to diagnostic test.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
consistency of the diagnosticians' results by investigators.
Time frame: From first dose of study drug to end of treatment (up to approximately 7 days)
To evaluate the safety and tolerability of HRS-6213.
Contact information is provided by the study sponsor or research team.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase I/II Clinical Study to Evaluate the Safety, Radiation Dosimetry, Pharmacokinetics, and Preliminary Diagnostic Efficacy of HRS-6213 in Healthy Subjects and Patients With Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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