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
Visit trial
Status Completed
Results Published
Start date 25 February 2020
End date 08 April 2021
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 20
Sex All
Therapy No

Trial Details

Part 1 is a randomised, placebo-controlled, double-blind, safety and tolerability study of single ascending doses of PCN-101 administered via intravenous (IV) infusions over 40 minutes to healthy volunteers. A total of up to 48 healthy volunteers will be enrolled in Part 1. The study will evaluate safety, tolerability and pharmacokinetics (PK) of PCN-101. The starting dose is 5mg (cohort 1) and this will be escalated in each subsequent cohort (15mg, 30mg, 60mg, 100mg and 150mg) Part 2 is a double-blind, crossover relative safety and tolerability study comparing a single dose of PCN-101 to esketamine. A total of 10 healthy volunteers will be randomised into one of 2 treatment groups. Treatment Group 1 will receive a single IV infusion over 40 minutes of PCN-101, then 48-hours later will receive a second IV infusion of esketamine. In Treatment Group 2, the order of infusions will be reversed. Part 2 will use the identified dose from Part 1 for PCN-101 and 15mg esketamine .

Trial Number PA7

Data attribution

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