A Double-blind, Randomized, Placebo-controlled, Phase 1 Safety and Tolerability, and Pharmacokinetics Study of ANAVEX3-71
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) of ANAVEX3-71
研究概览
简要总结
A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics
详细描述
This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and bioavailability of orally administered ANAVEX3-71 in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male or female between 18 and 55 years of age, inclusive.
- •Body mass index (BMI) between 19-28 kg/m2 and within a body weight of ≥ 60 kg and ≤ 120 kg.
- •Female subjects must be of non-childbearing potential (defined as postmenopausal for at least 2 years or surgically sterile at least 6 months prior to dosing) or must be using adequate contraception.
- •Subject is judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12-lead electrocardiogram (ECG).
- •Non-smoker (no tobacco use within past 3 months).
- •Subject is willing to comply with the study protocol, in the investigator's judgement.
排除标准
- •Subject has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, hematological (including myelosuppression and bleeding disorders) or immunological/autoimmune disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs.
- •Positive test result on Hepatitis B surface antigen (HBsAg) or is Hepatitis C virus antibody (HCV-Ab) positive or positive HIV-1 and/or -2 serology.
- •Subject has a history of chronic alcohol abuse within the last 2 years, or has a positive alcohol test or is known to have excessive alcohol intake.
- •History of substance abuse, known drug addiction, or positive test for drugs of abuse.
- •Subject has participated in another clinical trial of an investigational drug (or a medical device) within the last 3 months or is currently participating in another trial of an investigational drug (or a medical device).
- •Female subject who is pregnant or lactating or planning a pregnancy.
- •A history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to participate in the study (psychosis is to be disqualified).
- •Subject has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
研究组 & 干预措施
ANAVEX3-71 Oral
Up to four single ascending doses of ANAVEX3-71 administered orally
干预措施: ANAVEX3-71 (Drug)
Placebo arm Oral
Placebo administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of ANAVEX3-71
时间窗: 30 days
Serum concentration of ANAVEX3-71 at specified time points
Evaluation of safety and tolerability of ANAVEX3-71 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs) Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: 30 days
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
Maximum plasma concentration (Cmax) for ANAVEX3-71
时间窗: 30 days
Evaluate Cmax for serum concentration of ANAVEX3-71 at specified time points
Area under the curve concentration (AUC) for ANAVEX3-71
时间窗: 30 days
Evaluate AUC for serum concentration of ANAVEX3-71 at specified time points
次要结局
- Effect on ECG, including the ECG QT Interval(30 days)