None listed
Conditions
Brief summary
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.
Interventions
The study will be conducted in 2 parts.
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
The study will be conducted in 2 parts. 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 . The cohorts are mutually exclusive.
Sponsors
PERCEPTION NEUROSCIENCE, INC.
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria: • Able and willing to provide signed and dated informed consent • BMI within the range of 18 to 30, weighing between 50 kg and 100 kg • Healthy as determined by medical history, physical examination, and clinical laboratory evaluations • Male subjects must be sterile for at least 6 months or agree to use a double barrier method of contraception • Female subjects of child-bearing potential must be practicing a highly effective birth control • Female subjects of non-childbearing potential must be either surgically sterile or post-menopausal • Has a haemoglobin value of > 120 g/L at Screening
Exclusion criteria
Exclusion Criteria: •Pregnant or breast-feeding female • Has a primary diagnosis of current (active) generalised anxiety disorder, panic disorder, obsessive compulsive disorder, post traumatic stress disorder, anorexia nervosa, or bulimia nervosa • Has an active psychotic disorder within 10 years of Baseline • Is taking compound(s) known to induce or inhibit cytochrome P450 oxidase (CYP) drug metabolising enzymes • Has clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline • Has hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or any history of a hypertensive crisis • Has an abnormal ECG of clinical relevance at Screening or Baseline • Has past history of seizures • Has received an investigational drug or participated in a clinical trial within 30 days of Screening • Has a drug or alcohol abuse disorder within the past 5 years prior to Baseline or there is reason to believe a subject has such a history • Has smoked tobacco, used tobacco or nicotine products (including e-cigarettes) in the past 6 months prior to Baseline
Outcome results
None listed