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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic test: Static - PET/CT scan

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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/m2.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A non-radiolabeled GEH200520 - 1 mg	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
Experimental: A non-radiolabeled GEH200520 - 2 mg	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
Experimental: A non-radiolabeled GEH200520 - 4 mg	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
Experimental: A non-radiolabeled GEH200520 - 6 mg	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
Experimental: A non-radiolabeled GEH200520 - 8 mg	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
Experimental: A non-radiolabeled GEH200520 - 10 mg	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
Experimental: A non-radiolabeled GEH200520 - 12 mg or 15 mg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all TEAEs	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.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiation dosimetry and biodistribution of GEH200521 (18F) Injection after the GEH200520 Injection mass doses.	7 days
Optimal imaging window post-GEH200521 (18F) Injection after the GEH200520 Injection mass doses.	7 days
Mass dose of GEH200520 Injection followed by a fixed dose of GEH200521 (18F) Injection to achieve a diagnostic positron emission tomography (PET) image quality.	7 days
Pharmacokinetic property of the area under the curve (AUC) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.	7 days
Pharmacokinetic property of Cmax of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.	7 days
Pharmacokinetic property of clearance (CL) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.	7 days
Pharmacokinetic property volume of distribution (V) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.	7 days
To characterise the pharmacokinetic property of the elimination half-life (t1/2) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.	7 days
Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs.	7 days
Proportion of subjects with clinically significant abnormalities detected during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F).	7 days
Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results following administration of GEH200520 and GEH200521 (18F).	7 days
Proportion of subjects with clinically significant abnormalities detected for haematology test results following administration of GEH200520 and GEH200521 (18F).	7 days
Proportion of subjects with clinically significant abnormalities detected for beats per minute following administration of GEH200520 and GEH200521 (18F).	7 days
Changes in systolic and diastolic blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F).	7 days
Changes in temperature as degree F following administration of GEH200520 and GEH200521 (18F).	7 days
Proportion of subjects with clinically significant abnormalities detected during 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F).	7 days
Incidence of treatment induced and treatment enhance anti drug antibody responses following administration of GEH200520 and GEH200521 (18F)	7 days
Test-retest imaging reliability of GEH200521 (18F) Injection co-administered with the selected mass dose of GEH200520 Injection, when administered on 2 different days	13 days

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Fortrea; PPD Development, LP
• Investigators: Study Director: Yaron Raiter, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): February 19, 2026
• Study Completion (Actual): February 23, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: GE-269-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No