Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
Study Details
Study Description
Brief Summary
Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: [68Ga]-NOTA-hGZP (CSB-111) Injection Eligible participants will receive a single IV injection of CSB-111 up to 40 micro grams |
Drug: CSB-111
[68Ga]-NOTA-hGZP is a PET imaging agent.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Organ-level dosimetry of CYB-111 and total body and effective dose [PET/CT imaging up to 180 minutes post-injection]
milli-Sieverts [mSi]
- Percentage of intact CYB-111 in blood samples up to 65 min after injection, using HPLC [up to 65 minutes after injection]
Intact CYB-111 percentage in blood
- Total radioactivity via gamma counter of cell pellet, plasma protein and unbound radioactivity in blood samples up to 65 min [up to 65 minutes post dose]
milli-Curies [mCi]
- Concentration of intact CYB-111 in urine [up to 4 hours after injection or until below the level of detection]
Intact CYB-111 in urine in picograms
- Percentage of intact CYB-111 in urine [up to 4 hours after injection or until below the level of detection]
Percentage of intact CYB-111 in urine compared to initial dose
Secondary Outcome Measures
- Overall AEs frequency and frequency per grade of AEs related to CYB-111 according to Medical Dictionary for Regulatory Activities (MedDRA)/ Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 [up to 2 days post dose]
Overall AEs frequency and frequency per grade of AEs. All AE's in this study will be listed as an endpoint.
Other Outcome Measures
- Regional (organ) accumulation of CYB-111 [PET/CT imaging up to 180 minutes post-injection or until below limits of detection]
Dosimetry in organs in milli-Sieverts [mSi]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female healthy participants aged between 18 and 65 years old.
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For females of childbearing potential, a negative serum or urine beta-human chorionic gonadotropin (β-hCG) pregnancy test must be obtained at the day of the procedure prior to CYB-111 administration.
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Willing and able to undergo all study procedures.
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Willing and able to understand the written informed consent and sign the consent document prior to any study-related procedure.
Exclusion Criteria:
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History of allergic reactions to compounds of similar chemical or biologic composition to CYB-111.
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Prior malignancy except for fully resected skin cancers.
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Current treatment with systemic steroids, or immunosuppressive agents.
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Known renal or hepatic disease.
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Laboratory values:
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Leukocytes <3000/mcL
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Absolute neutrophil count <1500 mcL
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Platelets <100,000 mcL
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Total bilirubin >1.5 x Upper limit of normal (ULN)
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Aspartate Transaminase (AST)/ Alanine Aminotransferase (ALT) >2.5 x ULN
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Albumin <3.7 g/dL
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Gamma glutamyl transferase (GGT) >2.5 ULN
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eGFR <60 mL/min/1.73 m2 measured in the prior 30 days before administration of CYB-111
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Having received any investigational product in the prior three months of receiving CYB-111.
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Currently participating in any clinical trials, except observational studies.
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Any acute or chronic inflammatory disease, autoimmune disorders, or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results such as infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
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Participants who have any condition that would prevent them from receiving a PET scan.
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Female participants who are pregnant (confirmed via a positive serum or urine β-hCG test on the day of procedure prior to CYB-111 administration).
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Female participants who are breastfeeding.
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Unable or unwilling to use adequate contraception prior to study, during study participation and for one week post-injection for both females and males.
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Any medical condition which, in the opinion of the investigator, may interfere with participation in the study and/or alter the biodistribution of CYB-111.
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Mentally incapacitated or unable to understand the informed consent.
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Participants who, in the opinion of the investigator, have underlying psychological conditions which may negatively impact their wellbeing if participating.
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Prisoners.
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Staff and family members of CytoSite.
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Staff reporting to the principal investigator (PI).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- Cytosite Biopharma Inc.
- University of Alabama at Birmingham
Investigators
- Study Director: Colin Miller, CytoSite Bio Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CYT-002-01