A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 491
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of Belatacept
研究概览
简要总结
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Signed Informed Consent
- •Target population: Healthy males and females.
- •Males and females, ages 18 to 55 years, inclusive.
- •Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
- •Women must not be breastfeeding
- •Men and WOCBP must agree to follow instructions for contraception
排除标准
- •History of TB, malignancy, any other chronic or acute infecton or disease.
- •History of acute or chronic medical illness
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- •History of allergy to belatacept or related compounds -
研究组 & 干预措施
Process E Belatacept
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
干预措施: Process E Belatacept (Biological)
Process C Belatacept
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
干预措施: Process C Belatacept (Biological)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of Belatacept
时间窗: Day 1 to Day 71
Cmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in nanograms per milliliter.
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.
时间窗: Day 1 to Day 71
(AUC\[INF\]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng\*h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA)
次要结局
- Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)(Day 1 to Day 71)
- Half Life (T-HALF)(Day 1 to Day 71)
- Time of Maximum Observed Serum Concentration (Tmax)(Day 1 to Day 71)
- Total Body Clearance (CLT)(Day 1 to Day 71)
- Volume of Distribution at Steady State (Vss)(Day 1 to Day 71)