A Study to Compare the Pharmacokinetics of Abatacept (BMS-188667) Drug Product Using Active Pharmaceutical Ingredient Manufactured With a High Concentration of Metals Relative to the Active Pharmaceutical Ingredient Manufactured With a Low Concentration of Metals
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Single-dose pharmacokinetic parameters: AUC 0-71 days (Area under the serum concentration-time curve from time zero to 71 days)
研究概览
简要总结
The purpose of this study is to determine whether the blood levels of abatacept drug product manufactured using High Metals and using Low Metals are comparable in healthy subjects.
详细描述
Compare the pharmacokinetic (PK) of High Metals abatacept relative to Low Metals abatacept following a single intravenous infusion of 750 mg in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body weight will be between 60 and 100 kg, inclusive
排除标准
- •Any significant acute or chronic medical illness
- •Any major surgery within 4 weeks of study drug administration
- •Smoking more than 10 cigarettes per day
- •Recent (within 6 months of study drug administration) drug or alcohol abuse
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
- •History of any significant drug allergy or asthma
- •Women who are pregnant or breastfeeding and/or unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
研究组 & 干预措施
Low Metal Abatacept
Reference
干预措施: Abatacept (Drug)
High Metal Abatacept
干预措施: Abatacept (Drug)
结局指标
主要结局
Single-dose pharmacokinetic parameters: AUC 0-71 days (Area under the serum concentration-time curve from time zero to 71 days)
时间窗: Over 71 days after single dose administered
Single-dose pharmacokinetic parameters: Cmax (Maximum observed serum concentration)
时间窗: Over 71 days after single dose administered
Single-dose pharmacokinetic parameters: AUC (INF) (Area under the serum concentration-time curve from time zero extrapolated to infinity)
时间窗: Over 71 days after single dose administered
次要结局
- Immunogenicity determination will be based on titers of anti abatacept and anti-CTLA-4-T antibodies in serum over time(Days 29, 57, and 71 after single dose administered)
- Safety assessments: adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests. The incidence of observed adverse events will be tabulated and reviewed for potential significance and clinical importance(Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71 after single dose administration)