ClinicalTrials.gov record NCT07617688

Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhaseEarly phase 1A very early study, usually in a small number of people, to learn how the body handles a treatment. It is not designed to show whether the treatment works.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase 1, open-label study enrolls about 6 healthy adults. Each participant receives a single IV dose of [18F]MODAG-009 followed by whole-body PET imaging (up to 6 hours) and safety checks, with a brief follow-up contact about 7 days later.

What it is studying. The study is testing how the PET tracer [18F]MODAG-009 distributes through the body, how it is metabolized and excreted, and the radiation dose organs receive after a single injection.

What the researchers hope to learn. To characterize the tracer's biodistribution, pharmacokinetics, metabolite profile, whole-body and organ radiation dosimetry, and to record safety and tolerability after a single dose.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is an open-label, single-center, phase 1 study to further characterize [18F]MODAG-009 in Healthy Volunteers (HV). Approximately 6 participants will be enrolled in this study. Each participant will receive a single dose of [18F]MODAG-009 radiotracer and undergo whole body PET imaging covering up to 10 bed positions to capture the whole body from skull vertex to mid-thigh.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • [¹⁸F]MODAG-009 PET Imaging

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is an open-label, single-center, phase 1 study to further characterize [18F]MODAG-009 in HVs. All eligible participants receive a single intravenous (IV) injection of [¹⁸F]MODAG-009 followed by whole-body PET imaging in up to 3 imaging sessions for up to 6 hours post-injection, according to an Image Acquisition Plan (IAP). Safety assessments include physical examination, vital signs, ECG, safety laboratory tests, and AE monitoring on the imaging day and at a follow-up contact 7 (+/-2) business days after tracer injection. Blood and urine sampling is performed for radiometabolite analysis and urinary radioactivity respectively, as specified in the IAP. Approximately 6 participants will be enrolled in this study. The target enrollment will be HVs.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Each participant receives a single intravenous injection of [18F]MODAG-009 and undergoes whole-body PET imaging (up to 3 sessions) covering skull to mid-thigh for up to about 6 hours after injection. Blood and urine samples are collected for metabolite and urine radioactivity analysis. Safety monitoring includes physical exam, vital signs, ECG, laboratory tests, and adverse-event monitoring on the imaging day and at a follow-up contact 7 (±2) business days after injection. The imaging day may last several hours and you will be monitored during and after the scans.

How the study is structured. Interventional, open-label, single-group diagnostic study. Participants get one intravenous injection of [18F]MODAG-009 and undergo whole-body PET imaging in up to three sessions over about 6 hours. Safety monitoring (physical exam, vital signs, ECG, lab tests, and adverse event tracking) is done on the imaging day and at a follow-up contact 7 (+/-2) business days later. Blood and urine samples are collected for radiometabolite analysis and urinary radioactivity.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Healthy Adult. Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
May 27, 2026
Primary completion
May 2027 (estimated)
Study completion
May 2027 (estimated)
Target enrollment
6 participants (estimated)
Last updated on registry
Jun 4, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
MODAG GmbH
Collaborators
  • XingImaging, LLC
  • Institute for Neurodegenerative Disorders

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Institute for Neurodegenerative Disorders and XingImaging, LLCRecruiting

    New Haven, Connecticut, 06510 · United States

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
phase 1 study
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
electrocardiogram
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
concomitant medication
Other medicines a participant takes during the study. Some must be reported; some are restricted.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
investigational agent
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
target enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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