Actively Recruiting
Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers
Led by MODAG GmbH · Updated on 2026-06-04
6
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
MODAG GmbH
Lead Sponsor
X
XingImaging, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, single-center phase 1 study to better understand the characteristics of [18F]MODAG-009 in healthy adult volunteers aged 18 to 60 years. The study aims to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of this PET radiotracer, focusing on safety and tolerability from baseline up to 7 days after injection. Participants will receive a single intravenous dose of [18F]MODAG-009 followed by whole-body PET imaging covering the area from the skull vertex to mid-thigh. Imaging sessions may include up to three scans within 6 hours post-injection. Blood and urine samples will be collected to analyze radiometabolites and urinary radioactivity. Safety assessments will be performed on the imaging day and about a week later. During the study, participants will undergo physical exams, vital sign checks, ECGs, laboratory tests, and adverse event monitoring. Researchers will measure safety and tolerability, biodistribution, pharmacokinetics, whole-body excretion, and radiation dose to organs during the 6-hour imaging period. Follow-up contact occurs 7 days post-injection to ensure participant safety. About six healthy volunteers will take part in this research lasting several days.
CONDITIONS
Brief Title
Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female
- Aged 18 to 60 years old
- In good health based on medical history, physical exam, vital signs, ECG, and lab tests at screening
- Able to comply with study procedures
- Able to understand and sign informed consent
- Females must be of non-childbearing potential or use highly effective birth control starting 14 days before until 24 hours after injection
- Females of childbearing potential must not be pregnant, breastfeeding, or planning pregnancy during the study
- Males with female partners of childbearing potential must use adequate contraception and avoid sperm donation for 90 days after injection
You will not qualify if you...
- Use of prescription drugs or herbal supplements within 4 weeks or over-the-counter medications within 2 weeks prior to dosing (acetaminophen allowed if documented)
- Participation in other clinical interventional studies within 4 weeks prior to dosing
- Exposure to radiation over 50 mSv in the past year
- Blood donation or loss of 400 ml or more within 8 weeks prior to dosing
- History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders
- Clinically significant lab or ECG findings
- History of immunodeficiency diseases, including positive HIV
- Positive Hepatitis B or C test
- History of drug or alcohol abuse in last 12 months
- Tobacco use within 3 months prior to screening
- Positive pregnancy test
- Women who are lactating or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 hours
Participants receive a single intravenous injection of [¹⁸F]MODAG-009 followed by whole-body PET imaging in up to 3 imaging sessions within 6 hours post-injection. Blood and urine samples are collected for analysis and safety assessments are performed on the imaging day.
1 imaging day with up to 3 imaging sessions (in-person)
Duration - 7 (+/-2) business days
Participants are monitored for safety through a follow-up contact approximately 7 (+/-2) business days after tracer injection to assess tolerability and any adverse events.
1 follow-up contact (remote or in-person)
Trial Site Locations
Total: 1 location
1
Institute for Neurodegenerative Disorders and XingImaging, LLC
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
J
Johannes Levin, MD
S
Stephanie Roman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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