New imaging agent tested in healthy people
NCT ID NCT07617688
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new radioactive tracer called [18F]MODAG-009 in 6 healthy adults. The goal is to see how the tracer moves through the body and how much radiation exposure it causes. Participants get one injection and then a full-body PET scan. This is an early-phase study with no direct treatment benefit.
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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 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2027
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: * Male or Female, * aged 18 to 60 years old * in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * Ability to comply with the study procedures. * Able to understand and sign written informed consent from the participant. * Male and Females must meet additional criteria specified below, as applicable * a. Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \[18F\]MODAG-009. (i. Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). ii. Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.) * b. Females of childbearing potential must not be pregnant, breastfeeding or lactating, or planning pregnancy during the duration of the study. * c. Males with female partners of childbearing potential must use adequate contraceptive methods and refrain from sperm donation for 90 days after injection of \[18F\]MODAG-009 Exclusion Criteria: * Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication / significant non-drug therapy. Participation in any clinical interventional studies within four (4) weeks prior to initial dosing or 5 half-lives of the investigational agent if known and longer than four (4) weeks. * Participants with a history of exposure to any radiation \>50 mSv/year (e.g., occupational or radiation therapy) over the past year. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation. * Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study. * Have clinically significant findings on laboratory evaluations. * Have clinically significant findings on ECG evaluation. * History of immunodeficiency diseases, including a positive HIV test result. * A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result. * History of drug or alcohol abuse within the 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. * History of tobacco product use within 3 months prior to screening, to be verified by urine cotinine screening. * Positive pregnancy test result, if female. * Women who are lactating and breastfeeding.
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Conditions
The condition(s) this trial relates to.
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 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
Locations
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Institute for Neurodegenerative Disorders and XingImaging, LLC
RECRUITINGNew Haven, Connecticut, 06510, United States
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