Can a new PET tracer reveal the Body's immune battles?
NCT ID NCT07774650
First seen Aug 19, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This early-stage trial is testing an experimental imaging agent that targets granzyme B, a protein released by immune cells during activity. The goal is to see how this tracer moves through the body and how much radiation it delivers, using PET/CT scans and blood samples. Up to 12 healthy adults will receive a single injection and be monitored for about 24 hours, with a follow-up call a week later. The study aims to determine if this tracer is safe and could be used in the future to visualize immune responses in various diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Granzyme-B targeted [Cu-64]-labeled PET radiotracer
- What this could lead to
- If successful, this could lead to a new imaging tool to visualize immune activity in the body, potentially improving diagnosis and monitoring of diseases like cancer and autoimmune conditions.
- What could go wrong
- This is an early, small study focused on safety and imaging properties, not treatment. The tracer may not distribute as expected or may not be suitable for future clinical use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult male or female participants 18-60 years of age judged to be in good health by the Investigator 2. No clinically significant laboratory abnormalities; all tests of liver and kidney function within normal limits 3. Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the ICF and this protocol 4. Female participants of childbearing potential and male participants who are fertile and have female partners of childbearing potential must agree to use adequate birth control throughout the study to the conclusion of follow-up. Exclusion Criteria: 1. Pregnant or breast-feeding female participants (female participants of childbearing potential must have negative pregnancy tests at Screening and pre-dose Day 0) 2. Inadequate venous access (at least two distinct access sites allowing for separate test agent administration and PK blood sampling are required) 3. Inability or unwillingness to undergo serial PET/CT imaging 4. Active infection or malignancy 5. Known or suspected inflammatory, autoimmune or fibrotic disease 6. Major surgery or other intensive medical treatment in the 3 months prior to planned study injection, as assessed by the investigator 7. Received a radioisotope within 7 physical half-lives of that radioisotope prior to planned study injection 8. Known allergy/hypersensitivity to PET/CT tracers or compounds similar to GzmB-Targeted Compounds 9. Concurrent participation in a clinical trial of investigational product(s) 10. Participation in other research protocols or clinical care where there was radiation exposure such that the exposure from the last year, in addition to the radiation exposure expected from participation in this clinical study, exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by US federal guidelines 11. Significant intercurrent illness or psychiatric illness/social situation that could place the participant at undue risk during study participation, significantly alter study outcomes, or affect participant compliance with study requirements for dosing and evaluation, as determined by the investigator
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Xing Imaging
RECRUITINGNew Haven, Connecticut, 06510, United States
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