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Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults

Not yet recruitingRegisteredCTG

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.

Details

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.

Topics:Healthy Volunteers

Registry

Registry linkNCT05894902