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 Healthcare1 site in 1 country22 target enrollmentJuly 2, 2024

ConditionsHealthy Volunteers

InterventionsStatic - PET/CT scan GEH200520 Injection and GEH200521 (18F) Injection

DrugsGEH200520 Injection and GEH200521 (18F) Injection

Overview

Phase: Phase 1
Intervention: Static - PET/CT scan
Conditions: Healthy Volunteers
Sponsor: GE Healthcare
Enrollment: 22
Locations: 1
Primary Endpoint: Incidence of all TEAEs
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2, 2024

End Date

February 23, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is able and willing to comply with all study procedures as described in the protocol, and has read, signed, and dated an informed consent form prior to any study procedures being performed.
•The subject is male or female ≥18 years of age.
•The subject has a body mass index (BMI) ≥18 and ≤35 kg/m
•The subject has no history of chronic medical illness or symptoms of active illness per Investigator's assessment.
•The subject has no clinically significant deviation from normal ranges in physical examination, ECG, and clinical laboratory parameters.
•Female and male contraception methods.

Exclusion Criteria

•Subject is using prescribed and/or non-prescribed medication which in the Investigator's opinion might impact subject safety or the study results.
•Subject has a known or suspected allergy to IMP and/or IMP ingredients.
•Subject has had a surgery within 8 weeks prior to enrollment or a surgery is scheduled during the study.
•Subject has been enrolled in this or another interventional clinical study within the 30 days before screening for this study or is actively participating in another clinical study with IMP(s).
•Subject has been enrolled in another clinical study with radiation or exposed to radiation due to medical practice, which in the Investigator's opinion might impact subject safety or the study results.
•Subject is pregnant, planning to become pregnant, or is lactating.
•Creatinine and liver function laboratory values higher than 1.5x upper limit ranges per local site clinical practice.