A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 2
- 主要终点
- To Assess the Immunogenicity of MSB11455 Compared to Neulasta
研究概览
简要总结
The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.
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
- Double (Participant, Investigator)
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
- •Participants who provide signed and dated written informed consent.
- •Participants with laboratory test results within predefined ranges.
- •Other protocol defined inclusion criteria could apply.
排除标准
- •Participants with known hypersensitivity to any component of US-Neulasta or MSB
- •Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
MSB11455
Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.
干预措施: MSB11455 (Drug)
US-Neulasta
Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.
干预措施: US-Neulasta (Drug)
结局指标
主要结局
To Assess the Immunogenicity of MSB11455 Compared to Neulasta
时间窗: From first dose up to end of study (Up to 3 months)
Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB)
次要结局
- Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)(Day 1 up to a maximum of 1 year)