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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 is a Phase 1 study that has completed, run by GE Healthcare. The registered enrollment target is 22 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06398730
The ClinicalTrials.gov registry entry for NCT06398730 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which GEH200520 Injection and GEH200521 (18F) Injection is the first listed.
NCT06398730 reports 0 study locations.
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.
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