NCT00638989已完成1 期
An Open-Label, Parallel-Group, Bioavailability Study to Assess the Pharmacokinetics of CAT-354 Following Subcutaneous and Intravenous Administration
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Absolute Bioavailability of CAT-354 After Subcutaneous Dose
研究概览
简要总结
To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.
详细描述
To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration of 150 milligram (mg) and 300 mg compared with 150 mg given intravenously.
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
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed and dated written informed consent is obtained prior to any study related procedure taking place
- •Males, aged 19-55 years
- •No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
- •A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
- •Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
- •A negative screen for drugs of abuse and alcohol
- •Body mass index (BMI) between 18-30 kilogram per square meter (kg/m^2), inclusive
- •No other clinically significant abnormality on history and clinical examination
- •Able to comply with the requirements of the protocol.
排除标准
- •Any active concomitant disease including psychological disorders
- •History of medication that might carry over effects into study
- •Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354
- •Participation in another investigational medicinal product study within 3 months of the start of this study or 5 half-lives of the previously administered investigational medicinal product (IMP), whichever is the longer except methodological studies in which no IMP was given
- •Any acute illness in the 2 weeks before Day 0 (Visit 2)
- •Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
- •Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first degree relative of the aforementioned
- •Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol
- •The subject's primary care physician recommends the subject should not take part in the study
- •Subjects with immunodeficiency disorders
- •Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
结局指标
主要结局
Absolute Bioavailability of CAT-354 After Subcutaneous Dose
时间窗: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
次要结局
- Dose Normalized Maximum Observed Concentration (Cmax/Dose)(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit(Day 0 and Day 56)
- Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Apparent Systemic Clearance (CL/F) After Intravenous Dose(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(Day 0 to 56)
- Time to Reach Maximum Observed Serum Concentration (Tmax)(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Volume of Distribution at Steady State (Vss) After Intravenous Infusion(Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Terminal Phase Elimination Half Life (t1/2)(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Maximum Observed Serum Concentration (Cmax)(Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
- Apparent Systemic Clearance (CL/F) After Subcutaneous Dose(Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56)
研究者
研究点 (2)
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