Progressive Supranuclear Palsy (PSP)Early Phase 1NCT07348276
First-in-Human Study for the Safety and Evaluation of Two 4R Tau Ligands as Potential PET Radioligands for Imaging Tau Protein in the Brain
A Early Phase 1 study testing [18F]ABBV-964i, [18F]ABBV-965i and Lead Candidate in people with Progressive Supranuclear Palsy (PSP) and Healthy Participants, run by Invicro at 1 site in United States.
Trial summary
This clinical study is being conducted to learn more about two new imaging drugs, called [18F]ABBV-964i and [18F]ABBV-965i, which are designed to help doctors see changes in the brain related to a condition called Progressive Supranuclear Palsy (PSP). PSP is a rare disease that affects movement, balance, and thinking. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Progressive Supranuclear Palsy (PSP), Healthy Participants
- What is being tested?
- [18F]ABBV-964i, [18F]ABBV-965i and Lead Candidate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 23 Mar 2026
- Phase
- Early 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females: PSP 40-80 years; HV 18-80 years
- Body weight: 43-120 kg (95-265 lb)
- Women of childbearing potential: abstinent or use 2 contraception methods (one barrier) during study and 30 days post last injection
- Men: use 2 contraception methods and refrain from sperm donation during study and 90 days post last injection
- Adequate circulation and normal clotting for arterial cannulation
- Sufficient mobility and ability to lie still for imaging
- Healthy Volunteers: informed consent, no clinically relevant findings, no cognitive impairment
- PSP Participants: informed consent or assent with LAR consent, clinical diagnosis per NINDS-SPSP criteria, MRI consistent with PSP, able to ambulate, tolerate MRI, comply with study procedures, caregiver available if needed
Who cannot join
- History of drug or alcohol abuse in past 12 months
- Clinically significant lab abnormalities or unstable illness
- Investigational drug/device use within 30 days
- Pregnant, lactating, or breastfeeding
- Significant comorbid conditions (GI, CV, hepatic, renal, etc.)
- Abnormal clotting parameters (if arterial sampling)
Show all 13Show fewer
- MRI contraindications (implants, claustrophobia) for PSP participants
- Use of OTC meds or supplements within 2 weeks (healthy volunteers)
- Use of anti-hemostasis meds within 2 weeks of arterial line placement for PSP participants
- Unable to lie still for 90 minutes
- Major surgery or significant blood loss within 4 weeks
- Positive for Hepatitis B, Hepatitis C, or HIV
- Deemed unsuitable by Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Invicro (dba Perceptive)
New Haven, Connecticut, 06510
About this study
Official title: First-in-Human Study for the Safety and Evaluation of Two 4R Tau Ligands ([18F]ABBV964i and [ 18F]ABBV-965i) as Potential PET Radioligands for Imaging Tau Protein in the Brain of Patients With Probable PSP and Healthy Volunteers
This clinical study is being conducted to learn more about two new imaging drugs, called [18F]ABBV-964i and [18F]ABBV-965i, which are designed to help doctors see changes in the brain related to a condition called Progressive Supranuclear Palsy (PSP). PSP is a rare disease that affects movement, balance, and thinking. These drugs are used with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called tau builds up. Tau buildup is linked to PSP and other brain diseases.
The main goal of this study is to find out if these imaging drugs are safe for people and if they work well to show tau in the brain. The study will also look at how the drugs move through the body and how much radiation they give off. Researchers hope this information will help develop better tools for diagnosing PSP and tracking how it changes over time.
Read more
Who can join? Adults who are healthy or who have PSP may be able to take part. Participants will have screening tests to make sure they qualify.
What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into three parts: Part A checks radiation levels in healthy volunteers, Part B looks at how the drugs work in the brain of PSP patients and healthy volunteers, and Part C (optional) repeats scans to see if results are consistent.
Why is this important? There is currently no cure for PSP, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PSP and similar conditions in the future.
Read the detailed description
This Phase 1, first-in-human study is designed to evaluate the safety, pharmacokinetics, biodistribution, and test-retest variability of two investigational PET radioligands, [18F]ABBV-964i and [18F]ABBV-965i, for imaging 4R Tau pathology in individuals with Progressive Supranuclear Palsy (PSP) and healthy volunteers (HV). The study is structured into three parts: Part A (Dosimetry), Part B (Proof-of-Concept), and Part C (Optional Test-Retest).
Part A involves low-dose whole-body PET imaging in HVs to determine radiation dosimetry using both tracers. Participants will receive intravenous injections of [18F]ABBV-964i and [18F]ABBV-965i in separate imaging sessions, followed by dynamic PET acquisitions and urine collection for dosimetry analysis. Dosimetry calculations will employ MIRD methodology and OLINDA software to estimate absorbed organ doses and effective whole-body dose.
Part B evaluates tracer kinetics and brain uptake in PSP and HV participants using dynamic brain PET imaging over approximately 120 minutes post-injection. Arterial and/or venous blood sampling will be performed for kinetic modeling, including radiometabolite analysis via HPLC and plasma free fraction determination. Quantitative modeling will include compartmental approaches and graphical methods, as well as simplified reference tissue models. Key metrics such as SUV, SUVR, VT, and DVR will be derived to characterize tracer binding and distribution. MRI co-registration will support VOI definition for regional analysis.
Part C, if conducted, will assess test-retest reproducibility of the selected tracer in PSP participants using repeated brain PET scans under similar conditions. Variability will be expressed as percentage difference between test and retest values for primary imaging endpoints.
Radiotracer administration will follow strict safety protocols, including dose limits (≤ 10 mCi per injection) and radiation exposure monitoring to ensure compliance with applicable guidelines. PET imaging will be performed on PET/CT systems with attenuation correction. Image reconstruction will utilize OSEM algorithms with scatter and random corrections applied.
Safety assessments include continuous AE monitoring, vital signs, ECGs, and laboratory evaluations at predefined timepoints. Participants will undergo screening procedures including MRI (for PSP), MMSE, PSPRS, and p-Tau217 plasma testing where applicable. Concomitant medications and procedural details (arterial line placement, Allen's test, infusion protocols) are specified to minimize risk and ensure scientific integrity.
The investigational tracers are formulated as sterile solutions for IV injection. Manufacturing and quality control will adhere to GMP standards. The study rationale emphasizes the need for selective 4R Tau imaging agents to advance diagnostic and therapeutic strategies for PSP and related tauopathies.
- Being tested
- [18F]ABBV-964i, [18F]ABBV-965i, Lead Candidate
- Keywords
- Tauopathy, Tau, PET Imaging, ABBV-965i, ABBV-964i, PSP, Progressive Supranuclear Palsy
- Medical subject headings
- Supranuclear Palsy, Progressive, Tauopathies, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]ABBV-964iDrug
PET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.
[18F]ABBV-965iDrug
PET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.
Lead CandidateDrug
Also called [18F]ABBV-965i, [18F]ABBV-964i
Preferred PET radiopharmaceuticals (between [18F]ABBV-964i and [18F]ABBV-965i) selective for tau, administered intravenously at doses up to 10 mCi.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Dosimetry | Experimental | Healthy participants receive [18F]ABBV-964i and [18F]ABBV-965i for PET imaging. Receives: Drug: [18F]ABBV-964i; Drug: [18F]ABBV-965i |
| Part B - Proof of Concept | Experimental | Participants receive [18F]ABBV-964i and [18F]ABBV-965i for PET imaging to see how the drugs work in the brain. Receives: Drug: [18F]ABBV-964i; Drug: [18F]ABBV-965i |
| Part C - Test-Retest (Optional) | Experimental | Participants receive two PET scans using the same drug to see if results are consistent. Receives: Drug: Lead Candidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of [18F]ABBV-964i and [18F]ABBV-965i: Incidence of Adverse Events
Incidence of adverse events (AEs) following administration of [18F]ABBV-964i and [18F]ABBV-965i.
Measured: Up to 13 weeks
Radiation dosimetry of [18F]ABBV-964i and [18F]ABBV-965i
Radiation absorbed dose estimates following administration of [18F]ABBV-964i and [18F]ABBV-965i, derived from PET imaging and dosimetry calculations.
Measured: Up to 13 weeks
Secondary outcomes (2)
Brain Uptake measured as Standardized Uptake Value (SUV) or equivalent
Quantitative assessment of uptake in brain regions measured by PET imaging.
Measured: Up to 13 weeks
Model-derived Pharmacokinetics parameters
Pharmacokinetic parameters of radiotracers derived from dynamic PET imaging and input functions.
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start17 Nov 2025
- Primary completion19 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear Palsy (PSP)Studies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invicro
- Sponsor type
- University, hospital or other
- Collaborators
- Enigma Biomedical USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348276
- Sponsor's protocol ID
- EPAA-2024-TR01
- Status last verified
- Jul 2026
- First submitted
- 26 Dec 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Study for the Safety and Evaluation of Two 4R Tau Ligands ([18F]ABBV964i and [ 18F]ABBV-965i) as Potential PET Radioligands for Imaging Tau Protein in the Brain of Patients With Probable PSP and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07348276
- Acronym / sponsor ID
- EPAA-2024-TR01
- Keywords
- Tauopathy, Tau, PET Imaging, ABBV-965i, ABBV-964i, PSP, Progressive Supranuclear Palsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- InvicroUniversity, hospital or other
- Collaborators
- Enigma Biomedical USA
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 16 Jan 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.
This clinical study is being conducted to learn more about two new imaging drugs, called [18F]ABBV-964i and [18F]ABBV-965i, which are designed to help doctors see changes in the brain related to a condition called Progressive Supranuclear Palsy (PSP). PSP is a rare disease that affects movement, balance, and thinking. These drugs are used with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called tau builds up. Tau buildup is linked to PSP and other brain diseases.
The main goal of this study is to find out if these imaging drugs are safe for people and if they work well to show tau in the brain. The study will also look at how the drugs move through the body and how much radiation they give off. Researchers hope this information will help develop better tools for diagnosing PSP and tracking how it changes over time.
Who can join? Adults who are healthy or who have PSP may be able to take part. Participants will have screening tests to make sure they qualify.
What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into three parts: Part A checks radiation levels in healthy volunteers, Part B looks at how the drugs work in the brain of PSP patients and healthy volunteers, and Part C (optional) repeats scans to see if results are consistent.
Why is this important? There is currently no cure for PSP, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PSP and similar conditions in the future.
Detailed description
This Phase 1, first-in-human study is designed to evaluate the safety, pharmacokinetics, biodistribution, and test-retest variability of two investigational PET radioligands, [18F]ABBV-964i and [18F]ABBV-965i, for imaging 4R Tau pathology in individuals with Progressive Supranuclear Palsy (PSP) and healthy volunteers (HV). The study is structured into three parts: Part A (Dosimetry), Part B (Proof-of-Concept), and Part C (Optional Test-Retest).
Part A involves low-dose whole-body PET imaging in HVs to determine radiation dosimetry using both tracers. Participants will receive intravenous injections of [18F]ABBV-964i and [18F]ABBV-965i in separate imaging sessions, followed by dynamic PET acquisitions and urine collection for dosimetry analysis. Dosimetry calculations will employ MIRD methodology and OLINDA software to estimate absorbed organ doses and effective whole-body dose.
Part B evaluates tracer kinetics and brain uptake in PSP and HV participants using dynamic brain PET imaging over approximately 120 minutes post-injection. Arterial and/or venous blood sampling will be performed for kinetic modeling, including radiometabolite analysis via HPLC and plasma free fraction determination. Quantitative modeling will include compartmental approaches and graphical methods, as well as simplified reference tissue models. Key metrics such as SUV, SUVR, VT, and DVR will be derived to characterize tracer binding and distribution. MRI co-registration will support VOI definition for regional analysis.
Part C, if conducted, will assess test-retest reproducibility of the selected tracer in PSP participants using repeated brain PET scans under similar conditions. Variability will be expressed as percentage difference between test and retest values for primary imaging endpoints.
Radiotracer administration will follow strict safety protocols, including dose limits (≤ 10 mCi per injection) and radiation exposure monitoring to ensure compliance with applicable guidelines. PET imaging will be performed on PET/CT systems with attenuation correction. Image reconstruction will utilize OSEM algorithms with scatter and random corrections applied.
Safety assessments include continuous AE monitoring, vital signs, ECGs, and laboratory evaluations at predefined timepoints. Participants will undergo screening procedures including MRI (for PSP), MMSE, PSPRS, and p-Tau217 plasma testing where applicable. Concomitant medications and procedural details (arterial line placement, Allen's test, infusion protocols) are specified to minimize risk and ensure scientific integrity.
The investigational tracers are formulated as sterile solutions for IV injection. Manufacturing and quality control will adhere to GMP standards. The study rationale emphasizes the need for selective 4R Tau imaging agents to advance diagnostic and therapeutic strategies for PSP and related tauopathies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A - Dosimetry | Experimental | Drug: [18F]ABBV-964i, Drug: [18F]ABBV-965iHealthy participants receive [18F]ABBV-964i and [18F]ABBV-965i for PET imaging. |
| Part B - Proof of Concept | Experimental | Drug: [18F]ABBV-964i, Drug: [18F]ABBV-965iParticipants receive [18F]ABBV-964i and [18F]ABBV-965i for PET imaging to see how the drugs work in the brain. |
| Part C - Test-Retest (Optional) | Experimental | Drug: Lead CandidateParticipants receive two PET scans using the same drug to see if results are consistent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females: PSP 40-80 years; HV 18-80 years
- Body weight: 43-120 kg (95-265 lb)
- Women of childbearing potential: abstinent or use 2 contraception methods (one barrier) during study and 30 days post last injection
- Men: use 2 contraception methods and refrain from sperm donation during study and 90 days post last injection
- Adequate circulation and normal clotting for arterial cannulation
Key exclusion criteria (13 listed)
- History of drug or alcohol abuse in past 12 months
- Clinically significant lab abnormalities or unstable illness
- Investigational drug/device use within 30 days
- Pregnant, lactating, or breastfeeding
- Significant comorbid conditions (GI, CV, hepatic, renal, etc.)
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 |
|---|---|---|
| [18F]ABBV-964iPET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi. | Drug | Part A - Dosimetry, Part B - Proof of Concept |
| [18F]ABBV-965iPET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi. | Drug | Part A - Dosimetry, Part B - Proof of Concept |
| Lead CandidateAlso: [18F]ABBV-965i, [18F]ABBV-964iPreferred PET radiopharmaceuticals (between [18F]ABBV-964i and [18F]ABBV-965i) selective for tau, administered intravenously at doses up to 10 mCi. | Drug | Part C - Test-Retest (Optional) |
Primary outcome
Safety of [18F]ABBV-964i and [18F]ABBV-965i: Incidence of Adverse Events
Time frame: Up to 13 weeks
Incidence of adverse events (AEs) following administration of [18F]ABBV-964i and [18F]ABBV-965i.
Radiation dosimetry of [18F]ABBV-964i and [18F]ABBV-965i
Time frame: Up to 13 weeks
Radiation absorbed dose estimates following administration of [18F]ABBV-964i and [18F]ABBV-965i, derived from PET imaging and dosimetry calculations.
2 secondary outcomes
Brain Uptake measured as Standardized Uptake Value (SUV) or equivalent
Time frame: Up to 13 weeks
Model-derived Pharmacokinetics parameters
Time frame: Up to 13 weeks
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 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Progressive Supranuclear Palsy (PSP)
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
Recruiting
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy
Palsy Supranuclear, Supranuclear Palsy, Progressive
RecruitingPhase 3
A Study to Evaluate the Efficacy of NIO752 in Participants With Progressive Supranuclear Palsy
Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)
Not yet recruitingObservational study
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]ABBV-964i, [18F]ABBV-965i and Lead Candidate in people with Progressive Supranuclear Palsy (PSP) and Healthy Participants, run by Invicro 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 13 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 10 Jul 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Safety of [18F]ABBV-964i and [18F]ABBV-965i: Incidence of Adverse Events (time frame: Up to 13 weeks). The study lists 2 primary outcomes in all. 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 10 Jul 2026.