Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine

Phase I randomized, single-dose, 6-sequence, 3-period crossover bioavailability study (n=17) in healthy adults ≥55 years comparing sublingual MELT-100 (midazolam 3 mg + ketamine 25 mg) with IV midazolam (2 mg) and IV ketamine (6 mg).

Primary focus on comparative pharmacokinetics/bioavailability; safety and tolerability assessed during confinement with vital signs, ECG, labs, and adverse event monitoring.