A Study to Evaluate Safety and Dosimetry of [18F]4-FDF, a New PET Imaging Agent for Inflammation

Phase 1 Evaluation of Novel Imaging Diagnostic Agent NeuCaVis in Healthy Volunteers

A standard imaging test used to look for disease in the body is a positron emission tomography (PET) scan. These scans use a small amount of a radioactive substance, called a radiotracer. The most commonly used radiotracer is FDG, which shows us how the body uses glucose (a type of sugar). However, because the brain and heart naturally use a lot of glucose, the images can have background 'noise' making it harder for doctors to see signs of disease in these organs.

NeuCaVis is a new type of radiotracer that is being investigated in this study. It works by showing us how the body uses different kind of sugar, fructose. Outside of the digestive system, fructose is not normally used by healthy tissues. It is only used for energy when inflammation is present.

The purpose of this study is to evaluate the safety, tolerability and how NeuCaVis is distributed in normal tissue throughout the body. This is the first time this is being tested in people.

Participants will undergo a series of PET/CT scans following an intravenous injection of NeuCaVis. The first will be 90 minutes, then a 25 minute break, followed by a 10 minute scan, a 105 minute break, then a final 10 minute scan. A follow up phone call will occur 1-3 days later. In the optional sub-set study, participants will return to the clinic approximately 1-2 weeks after the first scan. The additional PET scan is already used in medical care and involves administration of an approved PET radiotracer, [18F]FDG. Researchers would compare this scan to the study PET scan with NeuCaVis. For this standard of care scan, it would be necessary to fast (not to eat or drink anything, except water) for at least 12 hours prior to receiving the FDG radiotracer injection.

Inclusion Criteria:

1. Male or female, ages 18-55 years inclusively at time of consent
2. Body Mass Index (BMI) of 18 to 30 kg/m2, inclusively
3. Capable of providing informed consent
4. Able to speak and read in English or French
5. Able to comply with all study procedures (including fasting for 12 hours, lying still in a supine position for about 90 minutes)

Exclusion Criteria:

1. Known hypersensitivity NeuCaVis or its excipients
2. Blood glucose level higher than 200mg/dl at screening
3. Active viral infection at screening
4. Currently taking anti-inflammatory medications (e.g. ASA, NSAIDs, corticosteroids, immunomodulating agents, colchicine)
5. Any anatomical heart abnormality, or cardiovascular condition including acute cardiac condition, suspicion of cardiac inflammation, and/or coronary artery disease, that may confound the analysis of the data based on the investigator's clinical opinion.
6. Recent (in the past 6 months) history of head trauma
7. Abnormal and clinically significant results on the physical examination, vital signs, or laboratory tests at screening.
8. Clinically significant neurologic, neurodevelopmental, cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, or metabolic-endocrine disorder
9. Female participants who are pregnant, planning to become pregnant during the study or breastfeeding
10. If of childbearing potential, unwilling or unable to use of a highly effective method of contraception as outlined in the protocol for the duration of the study.
11. Any contraindication to PET or CT imaging.
12. Actively participating in other interventional clinical trial(s).
13. Unwilling to comply with study procedures, medication restrictions or attend all study visits
14. Any other condition that, in the opinion of the investigator, could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results.