Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers
MODAG GmbH
Summary
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.
Description
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 anal…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
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. N…
Interventions
- Drug[¹⁸F]MODAG-009 PET Imaging
Participants enrolled in the study will receive a single intravenous (IV) dose of \[¹⁸F\]MODAG-009 administered prior to PET imaging
Location
- Institute for Neurodegenerative Disorders and XingImaging, LLCNew Haven, Connecticut