Phase one study to evaluate the safety and dosimetry of \[68Ga\]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers.
This study aims to assess the safety and evaluate the dosimetry of CSB-111. This study will estimate organ dosimetry and the overall effective dose, a requirement for expanding the human use of a radiopharmaceutical.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
\[68Ga\]-NOTA-hGZP is a PET imaging agent.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Organ-level dosimetry of CSB-111 and total body and effective dose
milli-Sieverts \[mSi\]
Time frame: PET/CT imaging up to 180 minutes post-injection
Percentage of intact CSB-111 in blood samples up to 185 min after injection, using HPLC
Intact CSB-111 percentage in blood
Time frame: From 65 to 185 minutes after injection
Total radioactivity via gamma counter of cell pellet, plasma protein and unbound radioactivity in blood samples up to 65 min
milli-Curies \[mCi\]
Time frame: Up to to 185 minutes post dose
Concentration of intact CSB-111 in urine
Intact CSB-111 in urine in picograms
Time frame: up to 4 hours after injection or until below the level of detection
Percentage of intact CSB-111 in urine
Percentage of intact CSB-111 in urine compared to initial dose
Time frame: up to 4 hours after injection or until below the level of detection
Overall AEs frequency and frequency per grade of AEs related to CSB-111 according to Medical Dictionary for Regulatory Activities (MedDRA)/ Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Overall AEs frequency and frequency per grade of AEs. All AE's in this study will be listed as an endpoint.
Time frame: up to 2 days post dose
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