This is a Phase 1/2 study to evaluate the safety and tolerability of 18F-OP-801 in subjects with ALS, AD, MS, PD and age-matched HVs. 18F-OP-801 is intended as a biomarker for PET imaging of activated microglia and macrophages in regions of neuroinflammation.
Has the ability to understand and sign the written ICF and local medical privacy authorization forms, which must be obtained prior to the conduct of any study related procedures.
Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the local laboratory's defined ranges.
Male subjects: condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (i.e., vasectomy).
Surgical sterilization at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, bilateral oophorectomy, or salpingectomy);
Body weight >120 kg
Evidence of clinically significant or past medical history of hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies) or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism or excretion of study drug or place the subject at an unacceptable risk as a participant in this study
History of recurrent kidney or liver malignancy
Pacemaker or defibrillator or any non-removable metallic foreign objects in the body not compatible with MRI
Parallel
18F-OP-801
Drug18F Hydroxyl Dendrimer
The number of participants with treatment emergent adverse events (Safety and Tolerability)
Safety of single dose of 18F-OP-801 as measured by treatment-related adverse events as assessed by CTCAE v5.0
Measurement of biodistribution of 18F-OP-801 for each participant
Measure biodistribution of 18F-OP-801 using whole body PET/MRI or PET/computed tomography (CT) scans
Measurement of clearance of 18F-OP-801 for each participant
Measure clearance of 18F-OP-801 using whole body PET/MRI or PET/computed tomography (CT) scans
Assess ability of 18F-OP-801 to detect regions of neuroinflammation in ALS, AD, MS, and PD participants
Determine correlation between MRI and PET images in each subject, quantifying the extent of 18F-OP-801 uptake in the region of neuroinflammation relative to normal brain section in the same subject as measured by whole body PET/MRI or PET/CT scans
Assess test/retest imaging repeatability
Compare regional and global brain uptake of 18F-OP-801 on two separate occasions
Correlation between plasma biomarker levels and PET signal for each participant
Correlation of plasma levels for various biomarkers with brain PET signal
Evaluate timeframe for optimal CNS tracer uptake
Determine the timing of maximal 18F-OP-801 uptake in CNS tissue
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