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

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 2, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Healthy Volunteers
Interventions
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

Trial Locations (1)

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

collaborator

Fortrea

INDUSTRY

lead

GE Healthcare

INDUSTRY

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 | Biotech Hunter | Biotech Hunter