At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 9 enrolled
Drug / intervention
DaTSCAN™ Ioflupane (123I) Injectiondrug
Likely dose
DaTSCAN™ Ioflupane (123I) Injection 5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating DaTSCAN™ Ioflupane (123I) Injection for Healthy Subjects (HS). Completed, enrolled 9 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects (HS)
CountriesChina
CollaboratorsPPD Development, LP
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartMay 2021
Primary CompletionSep 2021
TodayJul 2026
First PostedSep 25, 2020
Enrollment StartMay 13, 2021
Primary CompletionSep 4, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.8 years ago
Interventions
DaTSCAN™ Ioflupane (123I) Injectiondrug
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.