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NCT06398730 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT06398730: Completed Phase 1 study, sponsored by GE Healthcare.
NCT06398730 is a Phase 1 study that has completed, run by GE Healthcare. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06398730, a Phase 1 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study 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 in part A and 34 days in part B. 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.
Primary Outcome
Incidence of all grading of TEAEs per National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 based on the causality to the IMPs.
Interventions
- DRUG GEH200520 Injection and GEH200521 (18F) Injection
- DIAGNOSTIC_TEST Static - PET/CT scan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2026-02-23 |
| Phase | Phase 1 |
What the finished NCT06398730 record still lists
NCT06398730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which GEH200520 Injection and GEH200521 (18F) Injection is the first listed.
NCT06398730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06398730 about?
NCT06398730 is a clinical study titled "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". 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 ...
What is the current status of trial NCT06398730?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2024-07-02. Estimated completion is 2026-02-23.
What interventions are being tested in trial NCT06398730?
The interventions under investigation include: GEH200520 Injection and GEH200521 (18F) Injection (DRUG), Static - PET/CT scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06398730?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06398730's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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