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

Completed · Early Phase 1

Conditions studied: Progressive Supranuclear Palsy (PSP), Healthy Participants

In brief

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.

Key facts

Study ID: NCT07348276
Run by: Invicro
People needed: 11
Starts: 2025-11-17
Expected to finish: 2026-03-23
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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)
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

Where it is running

Invicro (dba Perceptive) — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.