to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a phase 1 study to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.

Clinical Trial Description

Ga-68 is a positron-emitting radionuclide with short half-life of 68 minutes. Dolacga is a non-radiolabeled formulated drug product and will be reconstituted to become the finished radiopharmaceutical product Ga68-Dolacga Injection, a PET tracer specifically targeting to surface receptors of hepatocytes. The study aims to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers. ;

Study Design

Related Conditions & MeSH terms

Safety Issues

Clinical Trial Details

NCT number	NCT03908957
Study type	Interventional
Source	Institute of Nuclear Energy Research, Taiwan
Contact
Status	Completed
Phase	Phase 1
Start date	February 12, 2019
Completion date	August 9, 2019

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