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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Invicro
Study ID
NCT07348276
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants
  • Progressive Supranuclear Palsy (PSP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • [18F]ABBV-964i — DRUG
    PET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.
  • [18F]ABBV-965i — DRUG
    PET radiopharmaceuticals selective for tau, administered intravenously at doses up to 10 mCi.
  • Lead Candidate — DRUG
    Preferred PET radiopharmaceuticals (between \[18F\]ABBV-964i and \[18F\]ABBV-965i) selective for tau, administered intravenously at doses up to 10 mCi.

Study Details

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 Dates

Start date
Nov 17, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Part A - Dosimetry
    Healthy participants receive \[18F\]ABBV-964i and \[18F\]ABBV-965i for PET imaging.
  • Experimental: Part B - Proof of Concept
    Participants receive \[18F\]ABBV-964i and \[18F\]ABBV-965i for PET imaging to see how the drugs work in the brain.
  • Experimental: Part C - Test-Retest (Optional)
    Participants receive two PET scans using the same drug to see if results are consistent.

Primary Outcome Measure

Safety of [18F]ABBV-964i and [18F]ABBV-965i: Incidence of Adverse Events [ Time Frame: Up to 13 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Invicro (dba Perceptive)New HavenConnecticut06510
David Russell, M.D., Ph.D
203-401-4300

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Invicro (dba Perceptive)· New Haven, CT

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