Open-label, Phase I dose-ranging safety study (n=12) in healthy adults testing single oral doses of SM-001 (0.5, 1.0, 2.0 mL/kg) to assess safety and plasma biomarkers.
This Phase I open-label study consecutively assigns 12 healthy adult volunteers to one of three single-dose SM-001 groups (0.5, 1.0, 2.0 mL/kg) to evaluate safety, tolerability and systemic exposure.
Plasma levels of DMT, harmine, tetrahydroharmine and harmaline will be measured pre-dose and at 1, 2, 4, 8 and 24 hours post-dose; final in-person follow-up on Day 28.
SM-001 0.5 mL/kg oral single dose; n=4 (2M/2F).
SM-001 decoction of Banisteriopsis caapi and Psychotria viridis; 0.5 mL/kg; n=4 (2M/2F).
SM-001 1.0 mL/kg oral single dose; n=4 (2M/2F).
SM-001 decoction; 1.0 mL/kg; n=4 (2M/2F).
SM-001 2.0 mL/kg oral single dose; n=4 (2M/2F).
SM-001 decoction; 2.0 mL/kg; n=4 (2M/2F).