Injections for Healthy Volunteers

Overseen By Jane Bateman

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GE Healthcare

Must not be taking: Prescribed medications

Disqualifiers: Surgery, Pregnancy, Radiation exposure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new combination of injections, including the GEH200520 Injection, in healthy volunteers. Researchers aim to observe how the body processes these injections and identify any side effects. The trial focuses on understanding the drug's distribution and breakdown in the body. It seeks healthy volunteers without chronic illnesses and who are not taking medications that could affect the study. Participants should be willing to commit to a study lasting up to 34 days. As a Phase 1 trial, this research explores how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed or non-prescribed medications if the study investigator thinks they might affect your safety or the study results.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the GEH200520 and GEH200521 (18F) Injections are under testing to determine their safety and tolerability. Previous studies used these injections for imaging in patients with solid tumors, and they were generally well-tolerated, though specific side effects were not detailed.

As this trial is in its early stages, the primary goal is to assess safety, with close monitoring of any side effects or risks. Early-phase trials involve careful observation to ensure participant safety while researchers learn more about the treatment's effects on the body.

For those considering participation, this type of study aims to identify potential risks before the treatment sees wider use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the GEH200520 Injection because it offers a fresh approach to treatment with a focus on varied dosing options, ranging from 1 mg to 15 mg. This allows for tailored treatment protocols, which is quite different from the one-size-fits-all approach of many existing treatments. Additionally, the experimental inclusion of the GEH200521 (18F) Injection suggests potential advancements in diagnostic capabilities, possibly enhancing how effectively conditions are monitored and managed. These innovative approaches could lead to more personalized and precise healthcare solutions.

What evidence suggests that this trial's treatments could be effective?

Research has shown that GEH200520 and GEH200521 (18F) are used in PET scans, imaging tests that help doctors examine the body. Studies have evaluated these injections for safety in patients with solid cancers, and early results suggest they are generally safe for these tests. In this trial, participants will receive different dosages of the non-radiolabeled GEH200520 to further assess its safety and effects. These drugs target parts of the immune system that can help fight cancer, potentially highlighting important areas in the body during cancer imaging. However, no information currently exists on their effectiveness for other conditions or uses outside of imaging. ^{6 7 8 9 10}

Who Is on the Research Team?

Yaron Raiter

Principal Investigator

GE Healthcare

Are You a Good Fit for This Trial?

This clinical trial is open to healthy volunteers who want to participate in a study assessing the safety of two injections, GEH200520 and GEH200521 (18F), used together with PET/CT scans. The main goal is to see how well people tolerate these injections and how they are distributed in the body.

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

I don't have any chronic or active illnesses according to my doctor.

My BMI is between 18 and 35.

Exclusion Criteria

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 is pregnant, planning to become pregnant, or is lactating

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive GEH200521 (18F) Injection co-administered with GEH200520 Injection in a dose-escalation study

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• GEH200520 Injection
• GEH200521 (18F) Injection

Trial Overview

The trial involves giving participants two different injections, GEH200520 and radioactive GEH200521 (18F), followed by PET/CT scans. It's designed to gradually increase doses to find out what amount is safe while tracking how the drugs spread through the body over about a month.

How Is the Trial Designed?

Group I: A non-radiolabeled GEH200520 - 8 mg Experimental Treatment 2 Interventions

Group II: A non-radiolabeled GEH200520 - 6 mg Experimental Treatment 2 Interventions

Group III: A non-radiolabeled GEH200520 - 4 mg Experimental Treatment 2 Interventions

Group IV: A non-radiolabeled GEH200520 - 2 mg Experimental Treatment 2 Interventions

Group V: A non-radiolabeled GEH200520 - 12 mg or 15 mg Experimental Treatment 2 Interventions

Group VI: A non-radiolabeled GEH200520 - 10 mg Experimental Treatment 2 Interventions

Group VII: A non-radiolabeled GEH200520 - 1 mg Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Fortrea

Industry Sponsor

Trials

22

Recruited

5,800+

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

Published Research Related to This Trial

In a study involving 10 healthy male volunteers, the new PET tracer [18F]PSS232 demonstrated effective brain uptake and distribution patterns similar to the existing tracer [11C]ABP688, indicating its potential for imaging mGlu5 receptors in humans.

The tracer exhibited well-defined kinetics and a simple two-tissue compartment model, suggesting that [18F]PSS232 could be a reliable tool for measuring mGlu5 density without the need for complex blood sampling methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A first-in-man PET study of [18F]PSS232, a fluorinated ABP688 derivative for imaging metabotropic glutamate receptor subtype 5. Warnock, G., Sommerauer, M., Mu, L., et al.[2018]

The optimal method for preparing the radiolabeled compound [18F]CP 99,219 involves heating it with specific reagents at 160 degrees C for 15 minutes, achieving radiochemical yields of 15-30% and purities over 97%.

Biodistribution studies in rats showed that [18F]CP 99,219 accumulates significantly in various tissues, particularly in the intestine, liver, kidney, and stomach, indicating its potential for targeted therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-labeling and biodistribution of the novel fluoro-quinolone antimicrobial agent, trovafloxacin (CP 99,219). Babich, JW., Rubin, RH., Graham, WA., et al.[2019]

(18)F-fluoroestradiol ((18)F-FES) PET imaging allows for in vivo evaluation of estrogen receptor (ER) expression in breast cancer, which is crucial for determining prognosis and response to endocrine therapies.

This review highlights the potential of (18)F-FES PET not only as a predictive assay for ER expression but also as a method to assess the effectiveness of endocrine treatments in real-time, marking a significant advancement over traditional biopsy methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluoroestradiol PET: Current Status and Potential Future Clinical Applications. Liao, GJ., Clark, AS., Schubert, EK., et al.[2018]

The study evaluated the safety and dosimetry of the PET radioligand [18F]PF-06684511 in healthy volunteers, finding an effective dose similar to other 18F radioligands, which allows for repeated imaging of BACE1 in the brain.

The two-tissue compartment model (2TCM) was determined to be the most effective method for quantifying BACE1 levels, with test-retest variability indicating reliability, although the intraclass correlation coefficient was lower than expected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET imaging of beta-secretase 1 in the human brain: radiation dosimetry, quantification, and test-retest examination of [18F]PF-06684511. Arakawa, R., Takano, A., Stenkrona, P., et al.[2021]

GSK2647544, a specific inhibitor of lipoprotein-associated phospholipase A2 (Lp-PLA2), successfully crossed the blood-brain barrier in a study involving 4 healthy male subjects, indicating its potential for treating Alzheimer's disease.

The treatment was well tolerated with no significant safety concerns, and modeling suggests that a twice-daily dose of 102 mg could achieve approximately 80% inhibition of brain Lp-PLA2 activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the Brain Biodistribution of the Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Inhibitor [18F]GSK2647544 in Healthy Male Subjects. Huiban, M., Coello, C., Wu, K., et al.[2019]

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