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

PERCEPTION NEUROSCIENCE, INC.0 个研究点目标入组 58 人开始时间: 2020年2月24日最近更新: 2021年4月12日

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•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:
•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

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