Investigating how [18F]MODAG-009 behaves in the body of healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label phase 1 study in healthy adults to characterize the pharmacokinetics, biodistribution, and radiation dosimetry of [18F]MODAG-009. About six participants will receive a single IV dose of the radiotracer and undergo whole-body PET scans across up to ten bed positions over several hours. Safety will be monitored with physical exams, vital signs, ECGs, labs, and adverse event tracking, plus blood and urine samples for radiometabolite and radioactivity analysis. The study also includes a follow-up contact about a week after injection. Eligibility requires good health, informed consent, and gender-specific contraception criteria as applicable.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute for Neurodegenerative Disorders and XingImaging, LLC
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Neha Prakash, MBBS — Institute for Neurodegenerative Disorders
• Study coordinator: Johannes Levin, MD
• Email: levin@modag.net
• Phone: 475-318-8250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.