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NCT06398730

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

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 Following GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers
GE Healthcare·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
GEH200520 Injection and GEH200521 (18F) Injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GE Healthcare
Location
Nashville, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 01, 2024
End date
May 01, 2025
Enrollment
24 participants
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
Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06398730
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06398730 through Pure Global AI's free database. This Phase 1 trial is sponsored by GE Healthcare and is currently Not yet recruiting. The study focuses on Healthy Volunteers. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.