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

NCT ID: NCT05285696

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-05-20

Brief Summary

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

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[68Ga]-NOTA-hGZP (CSB-111) Injection

Eligible participants will receive a single IV injection of CSB-111 up to 40 micro grams

Group Type: EXPERIMENTAL

CSB-111

Intervention Type: DRUG

\[68Ga\]-NOTA-hGZP is a PET imaging agent.

Interventions

CSB-111

\[68Ga\]-NOTA-hGZP is a PET imaging agent.

Intervention Type: DRUG

Other Intervention Names

[68Ga]-NOTA-hGZP

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Cytosite Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Miller

Role: STUDY_DIRECTOR

CytoSite Bio Inc.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

CYT-002-01

Identifier Type: -

Identifier Source: org_study_id