drugset / Trial / NCT03995888

Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer

NCT03995888

Phase 1 Completed 24 enrolled Blue Earth Diagnostics
Non-randomizedSequentialOpen-labelDiagnostic

Summary

A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer.

Timeline

Start
2019-06-11
Primary completion
2020-04-16
Completion
2020-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-rhPSMA-7.3 Diagnostic / imaging agent 300 mbq Intravenous

Indications