NCT00439881已完成1 期
A Study to Assess the Safety and Tolerability of SB-681323 Administered Via the Intravenous Route
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Safety of SB-681323 in terms of frequency/ nature of adverse events and changes in ECG patterns, vital signs and clinical laboratory parameters (including liver function tests) seen upto 48h after a single intravenous dose.
研究概览
简要总结
SB-681323 inhibits the action of an enzyme which is known to contribute to the inflammation seen in such conditions as Chronic Obstructive Pulmonary Disease and Rheumatoid Arthritis. This study will explore the safety of this drug and its blood levels when given in intravenous form to healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A healthy male aged between 25 and 55 years, inclusive, at the time of screening.
- •Body weight = 60 kg and a Body Mass Index within the range of 19 to 32 kg/m2 inclusive.
- •Must have given informed consent and signed the study consent form prior to taking part in any study procedures.
- •Have no significant abnormality on clinical examination.
- •Show no abnormality on haematology, clinical chemistry or urinalysis examination at the pre-study medical examination.
- •Demonstrate a clinically normal 12-lead ECG at screening
- •Liver function tests within the reference range at screening (ALT, AST, ALP, GT and bilirubin)
- •Do not show evidence of pre-study HIV and hepatitis B and C at screening
- •Do not show a positive pre-study urine drug screen
排除标准
- •Taken prescription or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) before the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
- •Show a history or evidence of drug or alcohol abuse.
- •Show a history of increased liver function tests (ALT, AST, bilirubin) above upper limit of normal (ULN) in the past 6 months (if known).
- •Demonstrate a history of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units). 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine.
- •Have a history or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Exposure prior to the first dosing day to more than 3 new medicinal entities within 12 months or has participated in a study with a new medicinal entity within 3 months or any other study within 2 months.
- •If participation in the study will result in the subject having donated more than 450 mL blood within a 3 month period.
- •On physical examination the subject is observed to have poor venous access.
- •An unwillingness of subjects to abstain from sexual intercourse with women; or unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of the first dose of investigational product until completion of the follow-up procedures.
结局指标
主要结局
Safety of SB-681323 in terms of frequency/ nature of adverse events and changes in ECG patterns, vital signs and clinical laboratory parameters (including liver function tests) seen upto 48h after a single intravenous dose.
次要结局
- Regular measurements of SB-681323 blood levels upto 48h after a single intravenous dose. Effects of SB-681323 in blood samples drawn upto 24h after intravenous dosing, on laboratory tests designed to explore the anti-inflammatory properties of the drug.
研究者
研究点 (2)
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