NCT04514796已完成1 期
A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- AUCinf
研究概览
简要总结
This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
40 mg/0.8 mL of SB5
Active Comparator
50 mg/mL of SB5
干预措施: Adalimumab (Drug)
40 mg/0.4 mL of SB5
Experimental
100 mg/mL of SB5
干预措施: Adalimumab (Drug)
结局指标
主要结局
AUCinf
时间窗: Day 1 to Day 57
Area under the concentration-time curve from time zero to infinity
Cmax
时间窗: Day 1 to Day 57
Maximum serum concentration
次要结局
- Tmax(Day 1 to Day 57)
- Vz/F(Day 1 to Day 57)
- %AUCextrap(Day 1 to Day 57)
- AUClast(Day 1 to Day 57)
- Incidence of treatment-emergent adverse events (TEAEs)(Day 1 to Day 57)
- λz(Day 1 to Day 57)
- t1/2(Day 1 to Day 57)
- Incidence of serious adverse events (SAEs)(Day 1 to Day 57)
- CL/F(Day 1 to Day 57)
- Incidence of neutralising antibodies (NAbs)(Day 1 to Day 57)
- Incidence of anti-drug antibodies (ADAs)(Day 1 to Day 57)
研究者
研究点 (1)
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