NCT07348276CompletedEarly phase 1
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
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 26 Dec 2025
- Start date
- 17 Nov 2025
- Primary completion date
- 19 Mar 2026
- Lead sponsor
- Invicro
- NCT number
- NCT07348276
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 11
- From 17 Nov 2025 to the primary completion date, 19 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Investigational drug/device use within 30 days
- MRI contraindications (implants, claustrophobia) for PSP participants
- Major surgery or significant blood loss within 4 weeks
Other illness
- History of drug or alcohol abuse in past 12 months
- Clinically significant lab abnormalities or unstable illness
- Significant comorbid conditions (GI, CV, hepatic, renal, etc.)
- Positive for Hepatitis B, Hepatitis C, or HIV
Other
- Pregnant, lactating, or breastfeeding
- Abnormal clotting parameters (if arterial sampling)
- 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
- Deemed unsuitable by Investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Invicro (dba Perceptive) Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.