BridgeMD
New treatment option for Healthy Adult
Official title Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers
ClinicalTrials.gov ID: NCT07617688
What this study is testing
What is [¹⁸F]MODAG-009 PET Imaging?
[¹⁸F]MODAG-009 PET Imaging is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary...
- 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...
- Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders...
- Have clinically significant findings on laboratory evaluations.
- Have clinically significant findings on ECG evaluation.
- History of immunodeficiency diseases, including a positive HIV test result.
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.