RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-02

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06398730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Yaron Raiter, MD

CONTACT

+31 (6) 21288463

Yaron.Raiter@gehealthcare.com

Jane Bateman

CONTACT

Jane.bateman@gehealthcare.com

Principal Investigator

Yaron Raiter

STUDY_DIRECTOR

GE Healthcare

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: GE Healthcare

Yaron Raiter, STUDY_DIRECTOR, GE Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-02

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteers