NCT05285696

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cytosite Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	CSB-111	\[68Ga\]-NOTA-hGZP is a PET imaging agent.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-04-01
• Completion: 2023-05-20
• First posted: 2022-03-17
• Last updated: 2023-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study