A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
研究概览
简要总结
This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males aged >18 and <65 years.
- •Signed and dated informed consent prior to any study-mandated procedure
- •Willing and able to comply with study requirements.
- •BMI >18.0 and <30.0 kg/m^2
- •Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
- •Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
排除标准
- •History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- •Any planned major surgery within the duration of the study.
- •Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
- •Regular use of any prescribed or non-prescribed medication
- •Planned treatment or treatment with another investigational drug within 3 months
- •Current smokers or users of nicotine products.
- •Positive screen for drugs of abuse or alcohol at screening
- •History of alcohol abuse or excessive intake of alcohol
- •Presence or history of drug abuse
- •History of, or current use of, anabolic steroids.
- •Excessive caffeine consumption
- •Plasma donation within one month of screening or blood donation during the 3 months prior to screening.
研究组 & 干预措施
ACD856
干预措施: ACD856 (Drug)
结局指标
主要结局
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
时间窗: 24 hours
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
AUC from time zero to time of last quantifiable analyte concentration
时间窗: 96 hours
a pharmacokinetic measure of the amount of study medication present in the blood
Total body clearance following iv administration
时间窗: 24 hours
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Area under the plasma concentration vs time curve from time zero extrapolated to infinity
时间窗: 24 hours
a pharmacokinetic measure of the amount of study medication present in the blood
Volume of distribution following iv administration
时间窗: 24 hours
a theoretical estimate of how much of the study drug that the body may contain
次要结局
- Number of subjects with clinically significant changes in vital signs(5 days)
- Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)(5 days)
- Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis(5 days)
- Number of subjects with adverse events(5 days)