Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

Phase 1 Study Evaluating the Safety of [11C]MeDAS Myelin-Targeting PET Agent in Humans

This study evaluates the safety of [11C]MeDAS, a PET radiotracer.

Myelin PET imaging provides a new type of information regarding the integrity of the central nervous system based on molecular imaging of myelin. Preclinical studies have shown [11C] MeDAS uptake in the brain and spinal cord to be an indicator of the microstructural integrity of the tissue.

[11C]MeDAS PET (Positron Emission Tomography) scans will be performed on healthy subjects at 2 timepoints to assess for safety of the radiotracer and to assess its performance in humans. Following measurement of [11C]MeDAS pharmacokinetics and biodistribution, an optimal protocol for dosing and imaging will be established.

Inclusion Criteria:

• Subject reports no known physical diseases of the central nervous system including no history of mental health disorders.
• Capable of giving informed consent
• Efforts will be made to include approximately equal numbers of women and men. Efforts will be made to include individuals of diverse ethnicities, as reflected in the local clinic population.

Exclusion Criteria:

• Age <18 or >65
• History of malignant hypertension or hypertensive crisis
• Known infectious disease requiring treatment during the course of the study
• Subject reported history of substance abuse
• inability to undergo an MRI or PET scan