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

NCT05285696 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-08-09

No results posted yet for this study

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

Interventions

DRUG

CSB-111

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Cytosite Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Miller · CytoSite Bio Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-04-01
Completion
2023-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285696 on ClinicalTrials.gov