LUCID-201-001: A Double-Blind, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Lucid-201
Double-blind, randomised, single-ascending-dose Phase I study (n=48) comparing single oral ascending doses of Lucid-201 (1,2,4,6 tablets by cohort) with 100 mg niacin active placebo in healthy volunteers and patients with mild-to-moderate depressive symptoms to assess safety, PK and PD.
Details
Randomised, double-blind, single-ascending dose (SAD) design with six cohorts (four healthy volunteer cohorts and two cohorts of participants with mild-to-moderate depressive symptoms); n=8 per cohort randomised 6:2 (Lucid-201:niacin).
Dosing under fasting conditions with mouth checks to verify swallowing; participants remain on site for a 3 day, 2 night period for pre- and post-dose assessments with safety monitoring up to 24 hours and PK/PD sampling at multiple timepoints including 0.25–24 hr post-dose.
Safety assessments include AEs/SAEs, vital signs, ECG, clinical labs, C-SSRS, and HAM-D for cohorts 5–6; subjective effects measured by VAS at specified timepoints.