Healthy VolunteersPhase 1NCT06398730
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
A Phase 1 study testing GEH200520 Injection and GEH200521 (18F) Injection and Static - PET/CT scan in people with Healthy Volunteers, run by GE Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GEH200520 Injection and GEH200521 (18F) Injection and Static - PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 23 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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
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
- Being tested
- GEH200520 Injection and GEH200521 (18F) Injection, Static - PET/CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEH200520 Injection and GEH200521 (18F) InjectionDrug
Administration of GEH200520 Injection followed by GEH200521 (18F) Injection
Static - PET/CT scanDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| A non-radiolabeled GEH200520 - 1 mg | Experimental | Not described Receives: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan |
| A non-radiolabeled GEH200520 - 2 mg | Experimental | Not described Receives: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan |
| A non-radiolabeled GEH200520 - 4 mg | Experimental | Not described Receives: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan |
| A non-radiolabeled GEH200520 - 6 mg | Experimental | Not described Receives: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan |
| A non-radiolabeled GEH200520 - 8 mg | Experimental | Not described Receives: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan |
| A non-radiolabeled GEH200520 - 10 mg | Experimental | Not described Receives: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan |
| A non-radiolabeled GEH200520 - 12 mg or 15 mg | Experimental | Not described Receives: Drug: GEH200520 Injection and GEH200521 (18F) Injection; Diagnostic Test: Static - PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (18)
Radiation dosimetry and biodistribution of GEH200521 (18F) Injection after the GEH200520 Injection mass doses.
Measured: 7 days
Optimal imaging window post-GEH200521 (18F) Injection after the GEH200520 Injection mass doses.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Pharmacokinetic property of clearance (CL) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
Measured: 7 days
Pharmacokinetic property volume of distribution (V) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
Measured: 7 days
To characterise the pharmacokinetic property of the elimination half-life (t1/2) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
Measured: 7 days
Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs.
Measured: 7 days
Proportion of subjects with clinically significant abnormalities detected during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F).
Measured: 7 days
Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results following administration of GEH200520 and GEH200521 (18F).
Measured: 7 days
Proportion of subjects with clinically significant abnormalities detected for haematology test results following administration of GEH200520 and GEH200521 (18F).
Measured: 7 days
Proportion of subjects with clinically significant abnormalities detected for beats per minute following administration of GEH200520 and GEH200521 (18F).
Measured: 7 days
Changes in systolic and diastolic blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F).
Measured: 7 days
Changes in temperature as degree F following administration of GEH200520 and GEH200521 (18F).
Measured: 7 days
Proportion of subjects with clinically significant abnormalities detected during 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F).
Measured: 7 days
Incidence of treatment induced and treatment enhance anti drug antibody responses following administration of GEH200520 and GEH200521 (18F)
Measured: 7 days
Test-retest imaging reliability of GEH200521 (18F) Injection co-administered with the selected mass dose of GEH200520 Injection, when administered on 2 different days
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start2 Jul 2024
- Primary completion19 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Fortrea
- Responsible party
- Sponsor
- Investigators
- Yaron Raiter, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398730
- Sponsor's protocol ID
- GE-269-004
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06398730
- Acronym / sponsor ID
- GE-269-004
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Fortrea
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEH200520 Injection and GEH200521 (18F) InjectionAdministration of GEH200520 Injection followed by GEH200521 (18F) Injection | Drug | 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 scanRepeat 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 | Diagnostic test | 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 |
Primary outcome
Incidence of all TEAEs
Time frame: 7 days
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.
18 secondary outcomes
Radiation dosimetry and biodistribution of GEH200521 (18F) Injection after the GEH200520 Injection mass doses.
Time frame: 7 days
Optimal imaging window post-GEH200521 (18F) Injection after the GEH200520 Injection mass doses.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Pharmacokinetic property of clearance (CL) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
Time frame: 7 days
Pharmacokinetic property volume of distribution (V) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
Time frame: 7 days
To characterise the pharmacokinetic property of the elimination half-life (t1/2) of total protein following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection.
Time frame: 7 days
Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs.
Time frame: 7 days
Proportion of subjects with clinically significant abnormalities detected during physical examination status by system organs following administration of GEH200520 and GEH200521 (18F).
Time frame: 7 days
Proportion of subjects with clinically significant abnormalities detected for serum biochemistry test results following administration of GEH200520 and GEH200521 (18F).
Time frame: 7 days
Proportion of subjects with clinically significant abnormalities detected for haematology test results following administration of GEH200520 and GEH200521 (18F).
Time frame: 7 days
Proportion of subjects with clinically significant abnormalities detected for beats per minute following administration of GEH200520 and GEH200521 (18F).
Time frame: 7 days
Changes in systolic and diastolic blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F).
Time frame: 7 days
Changes in temperature as degree F following administration of GEH200520 and GEH200521 (18F).
Time frame: 7 days
Proportion of subjects with clinically significant abnormalities detected during 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F).
Time frame: 7 days
Incidence of treatment induced and treatment enhance anti drug antibody responses following administration of GEH200520 and GEH200521 (18F)
Time frame: 7 days
Test-retest imaging reliability of GEH200521 (18F) Injection co-administered with the selected mass dose of GEH200520 Injection, when administered on 2 different days
Time frame: 13 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Raiter study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEH200520 Injection and GEH200521 (18F) Injection and Static - PET/CT scan in people with Healthy Volunteers, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all TEAEs (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.