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

NCT05285696 | Completed Phase 1 FDA Drug

• 1 other identifier: CYT-002-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

Secondary Outcomes (1)

• 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

  up to 2 days post dose

Other Outcomes (1)

• Regional (organ) accumulation of CSB-111

  PET/CT imaging up to 180 minutes post-injection or until below limits of detection

Study Arms (1)

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

EXPERIMENTAL

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

Drug: CSB-111

Interventions

CSB-111 DRUG

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

Also known as: [68Ga]-NOTA-hGZP

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of allergic reactions to compounds of similar chemical or biologic composition to CSB-111.
• Prior malignancy except for fully resected skin cancers.
• Current treatment with systemic steroids, or immunosuppressive agents.
• Known renal or hepatic disease.
• Laboratory values:
• Leukocytes \<3000/mcL
• Absolute neutrophil count \<1500 mcL
• Platelets \<100,000 mcL
• Total bilirubin \>1.5 x Upper limit of normal (ULN)
• Aspartate Transaminase (AST)/ Alanine Aminotransferase (ALT) \>2.5 x ULN
• Albumin \<3.7 g/dL
• Gamma glutamyl transferase (GGT) \>2.5 ULN
• eGFR \<60 mL/min/1.73 m2 measured in the prior 30 days before administration of CSB-111
• Having received any investigational product in the prior three months of receiving CSB-111.
• Currently participating in any clinical trials, except observational studies.

Sponsors & Collaborators

• Cytosite Biopharma Inc.: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Study Officials

• Colin Miller

  CytoSite Bio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: March 17, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 20, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)