NCT05981976已完成1 期
A Randomized, Open-Label, Parallel-Group, Single-dose, Relative Bioavailability Study of the Pharmacokinetics of Subcutaneous Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process J Relative to the Current Abatacept Drug Process F in Healthy Participants
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2023年8月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 3
- 主要终点
- Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
研究概览
简要总结
The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants, defined as having no clinically significant deviation from normal in medical history; physical examinations that would compromise the ability to participate, complete, and/or interpret the results of the study; 12-lead ECG; vital signs; and clinical laboratory results
- •Body weight between 60 and 100 kilograms (kg) inclusive, based on weight at screening
- •Participant must have a suitable injection site without tattoos, scarring, or other conditions in the upper, outer arm that could interfere with SC administration
排除标准
- •Present malignancy or previous malignancy within the last 5 years prior to screening
- •At risk for tuberculosis
- •Any chronic bacterial infection within the previous 12 weeks of dosing
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Abatacept Treatment B
Experimental
干预措施: Abatacept (Biological)
Abatacept Treatment A
Experimental
干预措施: Abatacept (Biological)
结局指标
主要结局
Area under the serum concentration-time curve from time zero to the last time of quantifiable concentration (AUC(0-T))
时间窗: Up to Day 71
Maximum observed serum concentration (Cmax)
时间窗: Up to Day 71
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC(INF))
时间窗: Up to Day 71
次要结局
- Time of maximum observed serum concentration (Tmax)(Up to Day 71)
- Number of laboratory-reported positive responses of anti-abatacept antibodies(Up to Month 12)
- Number of participants with adverse events (AEs)(Up to Month 12)
- Serum concentration at 168 hours after dosing (C168)(Up to Day 71)
- Number of participants with clinical laboratory abnormalities(Up to Month 12)
- Number of participants with vital sign abnormalities(Up to Month 12)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 71)
- Area under the serum concentration-time curve from time zero to 168 hours after dosing (AUC(0-168 hours))(Up to Day 71)
- Number of laboratory-reported positive responses of anti-CTLA4-T antibodies(Up to Day 71)
研究者
研究点 (3)
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