HealthyPhase 1NCT07853781
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
A Phase 1 study testing [11C]JMJ-129-d2 in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: PDE4D is a protein found in the brain. It helps control chemical signals that affect mood, memory, and thinking. Problems with PDE4D may play a role in depression and Alzheimer's disease. Being able to measure PDE4D levels in the body would help doctors identify and manage these diseases. Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [11C]JMJ-129-d2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to 5 Feb 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent under this protocol.
- Successful completion of screening under protocol 01M0254 or 17M0181 and confirmation of eligibility.
- Age 18 years or older.
- In good general health as determined by medical history, physical examination, vital signs, laboratory testing, and electrocardiogram.
- Willingness and ability to comply with all study procedures.
- Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Agree to adhere to the lifestyle considerations
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- Any current DSM-5-TR persistent psychiatric disorder, including but not limited to: schizophrenia spectrum and other psychotic disorders; bipolar and related disorders; and depressive disorders.
- History of neurologic illness or injury with the potential to affect study data interpretation.
- History of seizures, other than in childhood and related to fever.
- Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
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- Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- HIV Infection.
- Pregnancy or breast feeding.
- Participants must not have substance use disorder or alcohol use disorder.
- Unable to travel to the NIH.
- Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
- Known hypersensitivity to phosphodiesterase-4 (PDE-4) inhibitors (e.g. apremilast, roflumilast, crisaborole).
- Current use of any PDE4 inhibitor (e.g., apremilast, roflumilast, crisaborole), or use within 7 days prior to PET imaging.
- Taking CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, erythromycin, ritonavir); CYP3A4 inducers (e.g. phenobarbital St. John's Wort, rifampicin) or oral contraceptives containing gestodene and ethinyl estradiol, which may alter the metabolism and affect the kinetics of the study drug.
- Inclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.
- Pregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will perform a urine pregnancy test at screening and prior to all procedures to ensure participants are not pregnant. The test must be negative in order to continue on the study. In addition to completing a negative urine pregnancy test, on the day of PET scanning prior to PET scan procedures, participants of childbearing potential will undergo a clinical pregnancy screening interview with a licensed independent practitioner to confirm lack of pregnancy.
- Persons with HIV infection are excluded because HIV infection itself may change cAMP signaling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
PDE4D is a protein found in the brain. It helps control chemical signals that affect mood, memory, and thinking. Problems with PDE4D may play a role in depression and Alzheimer's disease. Being able to measure PDE4D levels in the body would help doctors identify and manage these diseases. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them see PDE4D in people more effectively.
Read more
Objective:
To test a new tracer ([11C]JMJ-129-d2) during imaging scans of the brain and body in healthy people.
Eligibility:
Healthy people aged 18 years and older. They must have been screened under protocols 01M0254 or 17M0181.
Design:
All participants will give samples of blood and urine. They will have a test of their heart function. A plastic tube will be inserted into a vein in their arm; the new tracer will be given through this tube.
Some participants will have 1 positron emission tomography (PET)/computed tomography (CT) scan of their whole body. They will lie on a padded bed that slides into a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.
Some participants will have 1 or 2 PET/CT scans of their brain only. Their head will be supported to keep it still during the scan. They will also have a magnetic resonance imaging (MRI) scan of the brain. MRI uses magnetic fields to capture images of the inside of the body. The MRI scan may require a second visit.
All participants will receive a follow-up call to check on their well-being 1 to 3 business days after their scans....
Read the detailed description
Study Description:
This is a Phase 1, first-in-human, single-site, open-label, sequential cohort study designed to evaluate the safety, biodistribution, metabolic stability, and quantitative brain imaging characteristics of the novel positron emission tomography (PET) radioligand [11C]JMJ-129-d2 in healthy volunteers. The study will proceed through staged cohorts including whole-body dosimetry, evaluation of brain imaging performance, and test-retest reproducibility. We hypothesize that [11C]JMJ-129-d2 will demonstrate acceptable safety, radiation dosimetry typical of 11C-labeled radioligands, and stable quantitative brain PET measures suitable for reproducible in vivo imaging of Phosphodiesterase 4D (PDE4D).
Objectives:
Primary Objective:
To evaluate the safety and quantitative brain imaging properties of [11C]JMJ-129-d2 in healthy volunteers.
Secondary Objectives:
- To estimate whole-body biodistribution and radiation dosimetry.
- To evaluate stability and reliability of regional total distribution volume (VT) in brain.
- To evaluate test-retest reproducibility of brain VT.
Endpoints:
Primary Endpoint:
Regional VT derived from kinetic modeling of dynamic brain PET data using a metabolite-corrected arterial input function.
Secondary Endpoints:
- Organ residence times and estimated effective radiation dose (rem).
- Regional VT time-stability metric in brain.
- Test-retest variability (TRV) and intraclass correlation coefficient (ICC) of regional VT in brain.
- Conditions
- Healthy
- Being tested
- [11C]JMJ-129-d2
- Keywords
- Kinetic Modeling, Dosimetry, Whole-body imaging, Brain Imaging, Phosphodiesterase 4D (PDE4D), Positron Emission Tomography (PET)/CT Imaging, 11C-JMJ-129-d2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]JMJ-129-d2Drug
Injected IV followed by PET scanning
| Study group | Role | What they receive |
|---|---|---|
| One-arm | Other | All subjects will receive the same tests. Receives: Drug: [11C]JMJ-129-d2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume of Distribution
Regional VT from kinetic modeling
Measured: 120 minutes
Secondary outcomes (1)
Dosimetry, ICC, aTRV, and biodistribution
Organ residence times and effective dose (rem); regional VT time-stability; test retest variability (TRV) and intraclass correlation coefficient (ICC) of regional VT.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start11 Nov 2026 (estimated)
- Primary completion22 Feb 2030 (estimated)
- Study completion5 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert B Innis, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853781
- Sponsor's protocol ID
- 10002720
- Other IDs
- 002720-M
- Status last verified
- 7 Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be submitted to ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07853781
- Acronym / sponsor ID
- 10002720
- Conditions
- Healthy
- Keywords
- Kinetic Modeling, Dosimetry, Whole-body imaging, Brain Imaging, Phosphodiesterase 4D (PDE4D), Positron Emission Tomography (PET)/CT Imaging, 11C-JMJ-129-d2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 22 Feb 2030 (estimated)
- Study completion
- 5 Feb 2031 (estimated)
- First posted
- 2 Oct 2026 (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.
Background:
PDE4D is a protein found in the brain. It helps control chemical signals that affect mood, memory, and thinking. Problems with PDE4D may play a role in depression and Alzheimer's disease. Being able to measure PDE4D levels in the body would help doctors identify and manage these diseases. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them see PDE4D in people more effectively.
Objective:
To test a new tracer ([11C]JMJ-129-d2) during imaging scans of the brain and body in healthy people.
Eligibility:
Healthy people aged 18 years and older. They must have been screened under protocols 01M0254 or 17M0181.
Design:
All participants will give samples of blood and urine. They will have a test of their heart function. A plastic tube will be inserted into a vein in their arm; the new tracer will be given through this tube.
Some participants will have 1 positron emission tomography (PET)/computed tomography (CT) scan of their whole body. They will lie on a padded bed that slides into a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body.
Some participants will have 1 or 2 PET/CT scans of their brain only. Their head will be supported to keep it still during the scan. They will also have a magnetic resonance imaging (MRI) scan of the brain. MRI uses magnetic fields to capture images of the inside of the body. The MRI scan may require a second visit.
All participants will receive a follow-up call to check on their well-being 1 to 3 business days after their scans....
Detailed description
Study Description:
This is a Phase 1, first-in-human, single-site, open-label, sequential cohort study designed to evaluate the safety, biodistribution, metabolic stability, and quantitative brain imaging characteristics of the novel positron emission tomography (PET) radioligand [11C]JMJ-129-d2 in healthy volunteers. The study will proceed through staged cohorts including whole-body dosimetry, evaluation of brain imaging performance, and test-retest reproducibility. We hypothesize that [11C]JMJ-129-d2 will demonstrate acceptable safety, radiation dosimetry typical of 11C-labeled radioligands, and stable quantitative brain PET measures suitable for reproducible in vivo imaging of Phosphodiesterase 4D (PDE4D).
Objectives:
Primary Objective:
To evaluate the safety and quantitative brain imaging properties of [11C]JMJ-129-d2 in healthy volunteers.
Secondary Objectives:
- To estimate whole-body biodistribution and radiation dosimetry.
- To evaluate stability and reliability of regional total distribution volume (VT) in brain.
- To evaluate test-retest reproducibility of brain VT.
Endpoints:
Primary Endpoint:
Regional VT derived from kinetic modeling of dynamic brain PET data using a metabolite-corrected arterial input function.
Secondary Endpoints:
- Organ residence times and estimated effective radiation dose (rem).
- Regional VT time-stability metric in brain.
- Test-retest variability (TRV) and intraclass correlation coefficient (ICC) of regional VT in brain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One-arm | Other | Drug: [11C]JMJ-129-d2All subjects will receive the same tests. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent under this protocol.
- Successful completion of screening under protocol 01M0254 or 17M0181 and confirmation of eligibility.
- Age 18 years or older.
- In good general health as determined by medical history, physical examination, vital signs, laboratory testing, and electrocardiogram.
Key exclusion criteria (18 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
- Any current DSM-5-TR persistent psychiatric disorder, including but not limited to: schizophrenia spectrum and other psychotic disorders; bipolar and related disorders; and depressive disorders.
- History of neurologic illness or injury with the potential to affect study data interpretation.
- History of seizures, other than in childhood and related to fever.
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 |
|---|---|---|
| [11C]JMJ-129-d2Injected IV followed by PET scanning | Drug | One-arm |
Primary outcome
Total Volume of Distribution
Time frame: 120 minutes
Regional VT from kinetic modeling
1 secondary outcome
Dosimetry, ICC, aTRV, and biodistribution
Time frame: 120 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The results will be submitted to ClinicalTrials.gov
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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.
Robert B Innis, M.D. principal investigator
National Institute of Mental Health (NIMH)
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 [11C]JMJ-129-d2 in people with Healthy, run by National Institute of Mental Health (NIMH) 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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 6 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tara N Turon, C.R.N.P. ((301) 827-6599, tara.turon@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Volume of Distribution (time frame: 120 minutes). 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 Nov 2026.