drugset / Trial / NCT04564092

A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.

NCT04564092 ↗

Phase 1 Completed 9 enrolled GE Healthcare PPD Development, LP · collab
NaSingle-groupOpen-labelDiagnostic

Summary

This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.

Timeline

Start
2021-05-13
Primary completion
2021-09-04
Completion
2021-09-04

Drugs

EvaluationDrugModalityDoseRoute
Subject [123I]ioflupane Diagnostic / imaging agent 111 mbq Intravenous

Indications

No indication recorded.