ISRCTN18263497已完成1 期
A randomised, double-blind, placebo-controlled, single and repeated dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AUT00201 in healthy male and female volunteers
Autifony Therapeutics (United Kingdom)0 个研究点目标入组 57 人开始时间: 2021年10月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
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 volunteer (groups other than Part A2) or healthy female volunteer (Part A2)
- •2. Aged 18–45 years (men) or 18–65 years (women)
- •3. A body mass index (BMI; Quetelet index) in the range 18.0–31.0
- •4. Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial
- •5. Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate
- •6. Agree to use effective contraception
- •7. Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication
- •8. Registered with a General Practitioner (GP) in the UK
- •9. Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS)
排除标准
- •1. Woman who is pregnant or lactating, or woman of child-bearing potential who is sexually active and not using a highly effective method of contraception (see section 11)
- •2. Clinically relevant abnormal history, physical findings, ECG, Holter, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer
- •3. Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer’s participation in the trial or make it unnecessarily hazardous.
- •4. Family history of seizures and history of seizures or recent head trauma. History or presence of epilepsy, severe head injury, unexplained blackouts, childhood
- •febrile seizures, chronic pain or any other chronic neurological condition or any psychiatric disorder (including but not limited to diagnosed anxiety disorders or
- •depression, family history of suicide, history of attempted suicide, etc)
- •5. Abnormal safety EEG at screening (Part A1 only)
- •6. Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness
- •7. Surgery (eg stomach bypass) or medical condition that might affect the absorption of medicines
- •8. Presence or history of severe adverse reaction to any drug
- •9. Use of a prescription medicine (except contraceptive implants in females) during the 28 days before the first dose of trial medication or use of an over-the-counter
- •medicine, herbal treatments or dietary supplements (including St John’s Wort), with the exception of acetaminophen (paracetamol) or multivitamins, during the 7 days before the first dose of trial medication
- •10. Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months (or 5 half-lives, whichever is longer)
- •before [first] admission to this study; in the follow-up period of another clinical trial at the time of screening for this study
- •11. Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly (for men) or 14 units of alcohol weekly (for women) or use of cigarettes or nicotine-containing products during the 3 months before the first dose until the end of the study
- •12. Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90–140 mm Hg systolic, 50–90 mm Hg diastolic; heart rate 40_100 beats/min. Borderline values (ie values that are = 5 mm Hg outside the relevant range for blood pressure, or 5 beats/min for heart rate) will be repeated. Subjects can be included if the repeat value is within range or still borderline, but deemed not clinically significant by the investigator
- •13. QT value, measured at the screening visit, greater than 450 msec for men or 470 msec for women on 12-lead ECG, using Fridericia’s formula (QTcF) for correction. Triplicate measurements will be made, and a mean QTcF value higher than 450 msec for men or 470 msec for women will lead to exclusion. A repeat (in triplicate) is allowed on one occasion for the determination of eligibility
- •14. Positive result for suicidal ideation or behaviour using the
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