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.
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.
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.
Single group
[¹⁸F]MODAG-009 PET Imaging
DrugParticipants enrolled in the study will receive a single intravenous (IV) dose of \[¹⁸F\]MODAG-009 administered prior to PET imaging
Safety and Tolerability
Incidence and severity of tracer-emergent Adverse events.
Biodistribution
Organ distribution and tissue kinetics of radioactivity.
Pharmacokinetics and Whole-body Excretion
Radiation absorbed dose estimates for organs
Organ Radiation Dosimetry and Effective Dose
Whole body effective dose estimate.
Pharmacokinetics and Whole-body Excretion
Blood metabolite characterization of \[18F\]MODAG-009 to determine metabolite fate and nature of metabolites.
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MODAG GmbH
Lead sponsor
XingImaging, LLC
Collaborator
Institute for Neurodegenerative Disorders
Collaborator
