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

This study in healthy volunteers aims to identify safe single doses of PCN-101 administered IV; to assess how the body handles IV PCN-101; and to compare the safety of PCN-101 and esketamine. The study aims to identify tolerable dosing of IV PCN-101 to be evaluated in future clinical trials.

Part 1 of the study is an ascending dose, double-blind safety and tolerability study of single doses of IV PCN-101. Up to 48 healthy volunteers will be enrolled to receive a single dose of PCN-101 or placebo, as an infusion over 40 minutes.

Part 2 is a double-blind, cross-over safety and tolerability study comparing a single dose of PCN-101 versus esketamine, both given IV over 40 minutes. Ten healthy volunteers will be randomized into one of two treatment groups.

Group 1 will receive a single infusion of PCN-101 and then an infusion of esketamine. In Group 2, the order of infusions will be reversed. Safety will be assessed via vital signs, 12-lead ECG, clinical laboratory tests, neuropsychological scales, sedation and adverse events.

Topic Depression Healthy Subjects
Compound Ketamine
Country New Zealand
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