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
Kanhai, K. M.; Zuiker, R.; Houghton, W.; Kramer, W.; McBride, K.; Moerland, M.; Dorfman, A.; McGlothlin, M.; Hotchkin, M.; Mortenson, M.; Etherington, R.; Groeneveld, G. J.
Show abstract
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 tmax 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.
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