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

Trial Summary

What is the purpose of this trial?

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. 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.

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.

What data supports the effectiveness of the drug GEH200521(18F)?

The research on (18)F-fluoroestradiol ((18)F-FES) PET shows that it can effectively measure estrogen receptor expression in breast cancer, which is important for predicting responses to hormone therapies. This suggests that GEH200521(18F), which may be similar, could have potential in assessing certain conditions in a similar way. ^{1 2 3 4 5}

Research Team

Yaron Raiter

Principal Investigator

GE Healthcare

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

(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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

18F-Fluoroestradiol PET: Current Status and Potential Future Clinical Applications. [2018]

2. Germany 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

18F-labeling and biodistribution of the novel fluoro-quinolone antimicrobial agent, trovafloxacin (CP 99,219). [2019]

4. United States 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. [2019]

5. Germany 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. [2018]