ISRCTN39003837已完成1 期
A Phase I, first-in-human, randomised, double-blind, placebo-controlled, single ascending oral dose, safety, tolerability and pharmacokinetic study to investigate the effects of OCT461201 in healthy volunteers
Oxford Cannabinoids Technologies Ltd.0 个研究点目标入组 32 人开始时间: 2023年5月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy male and female participants, between 18 and 55 years of age, inclusive, at the time of screening
- •2. Participant with a body mass index (BMI) of 18-30 kg/m2
排除标准
- •1. History of clinically significant neurological illnesses, head traumas or metabolic disorders.
- •2. Reports having experienced suicidal ideation (Type 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]) within 35 days prior to Screening, any suicidal behaviour within 2 years prior to Screening (Any Yes” answers on the Suicidal Behaviour section of C-SSRS), and/or the Investigator assesses the participant to be a safety risk to him/herself or others; in the last 2 years.
- •3. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within 30 days or five half-lives, whichever is longer, or exposure to more than four new chemical entities within 12 months before the first dose of IMP. (The washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
研究者
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