NCT03908957

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

An Open-label Phase I Clinical Trial to Assess the Safety of Ga68-Dolacga Injection in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Atomic Research Institute, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	Ga68-Dolacga Injection	Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv

Timeline

• Start date: 2019-02-12
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2019-04-09
• Last updated: 2020-02-13

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study