NCT04564092

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

A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects (HS)

Interventions

Type	Name	Description
DRUG	DaTSCAN™ Ioflupane (123I) Injection	Each participant will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.

Timeline

• Start date: 2021-05-13
• Primary completion: 2021-09-04
• Completion: 2021-09-04
• First posted: 2020-09-25
• Last updated: 2023-08-02
• Results posted: 2023-08-02

Locations

1 site across 1 country: China