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.
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
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
Sequential
[18F]ABBV-964i
DrugPET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.
[18F]ABBV-965i
DrugPET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.
Lead Candidate
DrugPreferred PET radiopharmaceuticals (between \[18F\]ABBV-964i and \[18F\]ABBV-965i) selective for tau, administered intravenously at doses up to 10 mCi.
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.
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.
Brain Uptake measured as Standardized Uptake Value (SUV) or equivalent
Quantitative assessment of uptake in brain regions measured by PET imaging.
Model-derived Pharmacokinetics parameters
Pharmacokinetic parameters of radiotracers derived from dynamic PET imaging and input functions.
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Invicro
Lead sponsor
Enigma Biomedical USA
Collaborator
