A Phase I Randomized, Placebo Controlled, Double-Blind, Single-Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PCN-101 (Arketamine) and a Relative Safety Comparison of PCN-101 and Esketamine in Healthy Volunteers
Phase I, randomized, double-blind, placebo-controlled study in healthy volunteers assessing single ascending IV doses of PCN-101 (arketamine) and a crossover relative safety comparison with esketamine (15 mg IV).
Details
The trial has two parts: Part 1 is a randomized, placebo-controlled, double-blind single-ascending-dose study of PCN-101 administered as 40‑minute IV infusions (cohorts: 5, 15, 30, 60, 100, 150 mg) enrolling up to 48 healthy volunteers to evaluate safety, tolerability and pharmacokinetics.
Part 2 is a double-blind crossover in 10 healthy volunteers comparing the identified PCN-101 dose from Part 1 with esketamine 15 mg IV; each subject receives two 40‑minute infusions 48 hours apart. Safety assessments include vital signs, 12‑lead ECG, clinical labs, neuropsychological scales, sedation and adverse events.