A Randomized, Open-label Study to Evaluate the Pharmacokinetics of a Single Subcutaneous Administration of 50 mg or 100 mg Golimumab in a Pre-filled Syringe Formulation to Healthy Male Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.
详细描述
This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 50 mg or 100 mg golimumab as a subcutaneous injection.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Have no clinically relevant abnormalities
- •non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.
排除标准
- •Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
- •Have any underlying physical or psychological medical condition
- •Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
研究组 & 干预措施
001
Golimumab Single dose of 50 mg subcutaneously
干预措施: Golimumab (Drug)
002
Golimumab Single dose of 100 mg subcutaneously
干预措施: Golimumab (Drug)
结局指标
主要结局
Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects
时间窗: Day 71 (Week 11)
次要结局
- Number of participants with adverse events(Day 71)
- Immunogenicity of golimumab, as measured by antibodies to golimumab(Day 71)