Assessing the safety and distribution of a new 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 study is testing a new injection in healthy volunteers to see how safe it is and how it moves through the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GE Healthcare (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06398730 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the safety, tolerability, pharmacokinetics, dosimetry, and biodistribution of GEH200521 (18F) Injection when co-administered with GEH200520 Injection in healthy volunteers. It is a single-center, open-label, single-arm, dose-escalation study designed to gather data on the effects of these injections. Participants will undergo a PET/CT scan to monitor the injections' behavior in the body over an estimated duration of 28 days.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 and older with a BMI between 18 and 35 who can comply with study procedures.

Not a fit: Patients with chronic medical illnesses or those on medications that could affect safety or study results may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved safety profiles and understanding of new imaging agents for future medical applications.

How similar studies have performed: While this approach is common in early-phase studies, the specific combination of these agents has not been extensively tested, making this a novel investigation.

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/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.

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Yaron Raiter, MD

Conditions Healthy Volunteers