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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GEH200520 Injection and GEH200521 (18F) Injection	Administration of GEH200520 Injection followed by GEH200521 (18F) Injection
DIAGNOSTIC_TEST	Static - PET/CT scan	Repeat whole body static scan starting 3 minutes after injection followed by a single whole body static scan at 2 to 3 hours after injection and 4 to 5 hours after injection

Timeline

• Start date: 2024-07-02
• Primary completion: 2026-02-19
• Completion: 2026-02-23
• First posted: 2024-05-03
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study