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

NCT06398730 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GE-269-004
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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

Study Arms (7)

A non-radiolabeled GEH200520 - 1 mg

EXPERIMENTAL

Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan

A non-radiolabeled GEH200520 - 2 mg

EXPERIMENTAL

Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan

A non-radiolabeled GEH200520 - 4 mg

EXPERIMENTAL

Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan

A non-radiolabeled GEH200520 - 6 mg

EXPERIMENTAL

Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan

A non-radiolabeled GEH200520 - 8 mg

EXPERIMENTAL

Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan

A non-radiolabeled GEH200520 - 10 mg

EXPERIMENTAL

Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan

A non-radiolabeled GEH200520 - 12 mg or 15 mg

EXPERIMENTAL

Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan

Interventions

GEH200520 Injection and GEH200521 (18F) Injection DRUG

Administration of GEH200520 Injection followed by GEH200521 (18F) Injection

A non-radiolabeled GEH200520 - 1 mg; A non-radiolabeled GEH200520 - 10 mg; A non-radiolabeled GEH200520 - 12 mg or 15 mg; A non-radiolabeled GEH200520 - 2 mg; A non-radiolabeled GEH200520 - 4 mg; A non-radiolabeled GEH200520 - 6 mg; A non-radiolabeled GEH200520 - 8 mg

Static - PET/CT scan DIAGNOSTIC_TEST

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

A non-radiolabeled GEH200520 - 1 mg; A non-radiolabeled GEH200520 - 10 mg; A non-radiolabeled GEH200520 - 12 mg or 15 mg; A non-radiolabeled GEH200520 - 2 mg; A non-radiolabeled GEH200520 - 4 mg; A non-radiolabeled GEH200520 - 6 mg; A non-radiolabeled GEH200520 - 8 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• PPD Development, LP: collaborator
• Fortrea: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yaron Raiter

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 3, 2024
• Study Start: July 2, 2024
• Primary Completion: February 19, 2026
• Study Completion: February 23, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)