A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers - Trial NCT06398730
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Study Focus
Sponsor & Location
GE Healthcare
Timeline & Enrollment
Phase 1
May 01, 2024
May 01, 2025
Primary Outcome
Incidence of all TEAEs
Summary
This is a Phase 1, single-center, open-label, single-arm, dose-escalation positron emission
 tomography study to assess the safety and tolerability, immunogenicity, Pharmacokinetics,
 dosimetry, and biodistribution after GEH200521 (18F) Injection is co-administered with
 GEH200520 Injection in healthy volunteers.
 
 The estimated study duration for each subject is approximately 28 days.
 
 The primary study objective is to evaluate the safety and tolerability of the IMPs, the
 selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521
 (18F) Injection.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06398730
Non-Device Trial