Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.

A Phase 1 Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.

Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: CSB-111

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female healthy participants aged between 18 and 65 years old.
2. 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 CSB-111 administration.
3. Willing and able to undergo all study procedures.
4. Willing and able to understand the written informed consent and sign the consent document prior to any study-related procedure.
5. Willing to refrain from strenuous exercise for the 24 hours prior to CSB-111 administration

Exclusion Criteria:

1. History of allergic reactions to compounds of similar chemical or biologic composition to CSB-111.
2. Prior malignancy except for fully resected skin cancers.
3. Current treatment with systemic steroids, or immunosuppressive agents.
4. Known renal or hepatic disease.

5. Laboratory values:

   1. Leukocytes <3000/mcL
   2. Absolute neutrophil count <1500 mcL
   3. Platelets <100,000 mcL
   4. Total bilirubin >1.5 x Upper limit of normal (ULN)
   5. Aspartate Transaminase (AST)/ Alanine Aminotransferase (ALT) >2.5 x ULN
   6. Albumin <3.7 g/dL
   7. Gamma glutamyl transferase (GGT) >2.5 ULN
   8. eGFR <60 mL/min/1.73 m2 measured in the prior 30 days before administration of CSB-111
6. Having received any investigational product in the prior three months of receiving CSB-111.
7. Currently participating in any clinical trials, except observational studies.
8. 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.
9. Participants who have any condition that would prevent them from receiving a PET scan.
10. Female participants who are pregnant (confirmed via a positive serum or urine β-hCG test on the day of procedure prior to CSB-111 administration).
11. Female participants who are breastfeeding.
12. Unable or unwilling to use adequate contraception prior to study, during study participation and for one week post-injection for both females and males.
13. Any medical condition which, in the opinion of the investigator, may interfere with participation in the study and/or alter the biodistribution of CSB-111.
14. Mentally incapacitated or unable to understand the informed consent.
15. Participants who, in the opinion of the investigator, have underlying psychological conditions which may negatively impact their wellbeing if participating.
16. Prisoners.
17. Staff and family members of CytoSite.
18. Staff reporting to the principal investigator (PI).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: [68Ga]-NOTA-hGZP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ-level dosimetry of CSB-111 and total body and effective dose	milli-Sieverts [mSi]	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	From 65 to 185 minutes after injection
Percentage of intact CSB-111 in urine	Percentage of intact CSB-111 in urine compared to initial dose	up to 4 hours after injection or until below the level of detection
Total radioactivity via gamma counter of cell pellet, plasma protein and unbound radioactivity in blood samples up to 65 min	milli-Curies [mCi]	Up to to 185 minutes post dose
Concentration of intact CSB-111 in urine	Intact CSB-111 in urine in picograms	up to 4 hours after injection or until below the level of detection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 days post dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional (organ) accumulation of CSB-111	Dosimetry in organs in milli-Sieverts [mSi]	PET/CT imaging up to 180 minutes post-injection or until below limits of detection

Collaborators and Investigators

• Sponsor: Cytosite Biopharma Inc.
• Collaborators: University of Alabama at Birmingham
• Investigators: Study Director: Colin Miller, CytoSite Bio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CYT-002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No