Clinical TrialHealthy VolunteersKetaminePlaceboEsketamineCompleted

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).

Target Enrollment
58 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Arms & Interventions

PCN-101

experimental

Single-ascending IV doses of PCN-101 (arketamine); cohorts 5→150 mg, infusion over 40 minutes.

Interventions

  • Ketamine5 - 150 mg
    via IV• single dose

    Ascending single doses 5,15,30,60,100,150 mg via 40-minute IV infusion; Part 1 up to 48 subjects.

Placebo

inactive

0.9% saline IV placebo comparator.

Interventions

  • Placebo
    via IV• single dose

    0.9% normal saline over 40 minutes; used as placebo in Part 1 and Part 2.

Esketamine

active comparator

Esketamine 15 mg IV comparator in crossover (Part 2).

Interventions

  • Esketamine15 mg
    via IV• single dose

    15 mg IV over 40 minutes; Part 2 crossover (n=10) with 48 h between infusions.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Healthy volunteers; age 18–99 years; able to give informed consent; medically stable per screening assessments; non-pregnant and non-lactating for females of childbearing potential.

Exclusion Criteria

  • Pregnant or breast‑feeding female
  • Primary diagnosis of current (active) generalized anxiety disorder, panic disorder, obsessive compulsive disorder, post traumatic stress disorder, anorexia nervosa, or bulimia nervosa
  • Active psychotic disorder within 10 years of baseline
  • Taking compounds known to induce or inhibit cytochrome P450 enzymes
  • Clinically significant laboratory abnormalities at screening or baseline
  • Hypertension (systolic >140 mmHg or diastolic >90 mmHg) or history of hypertensive crisis
  • Abnormal ECG of clinical relevance at screening or baseline
  • Past history of seizures
  • Received an investigational drug or participated in a clinical trial within 30 days of screening
  • Drug or alcohol abuse disorder within the past 5 years prior to baseline or suspected history of such
  • Smoked tobacco or used nicotine products (including e-cigarettes) in the past 6 months prior to baseline

Study Details

Locations

Unknown facility — Australia

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