A first-in-human study in healthy subjects of the safety and pharmacokinetics of CNM-Au8, a suspension of catalytically active gold nanocrystals with remyelinating and neuroprotective properties

CNM-Au8 is a suspension of catalytically-active gold nanocrystals, developed to treat neurodegenerative disease. A first-in-human single- and multiple-ascending dose study was performed to assess safety and pharmacokinetics of CNM-Au8. The single-dose phase enrolled 40 subjects; the multiple-dose phase 48 subjects. Doses ranged from 15 to 90 mg CNM-Au8 and were administered by qualified clinical staff per os . Safety was assessed by adverse events, vitals, ECGs and laboratory measurements. The most frequently reported related adverse event was mild abdominal pain (20%) of transient nature. Plasma half-life was 11.5 to 26.2 days, a first dose t max ranged from 3.3 - 3.5 hours. CNM-Au8 displayed a safety profile and pharmacokinetic properties supportive of its advancement to Phase 2 and Phase 3 clinical trials.