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

August 5, 2023 updated by: Cytosite Biopharma Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Lieselotte Bloss, DVM

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Organ-level dosimetry of CSB-111 and total body and effective dose
Time Frame: PET/CT imaging up to 180 minutes post-injection
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
Time Frame: From 65 to 185 minutes after injection
Intact CSB-111 percentage in blood
From 65 to 185 minutes after injection
Percentage of intact CSB-111 in urine
Time Frame: up to 4 hours after injection or until below the level of detection
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
Time Frame: Up to to 185 minutes post dose
milli-Curies [mCi]
Up to to 185 minutes post dose
Concentration of intact CSB-111 in urine
Time Frame: up to 4 hours after injection or until below the level of detection
Intact CSB-111 in urine in picograms
up to 4 hours after injection or until below the level of detection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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.
up to 2 days post dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Regional (organ) accumulation of CSB-111
Time Frame: PET/CT imaging up to 180 minutes post-injection or until below limits of detection
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cytosite Biopharma Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Colin Miller, CytoSite Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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