NCT03100630已完成1 期
An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RO7239361 in Healthy Participants
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
- 99
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax)
研究概览
简要总结
Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.
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
- •Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
- •Body Mass Index 18 kg/m2 to 32 kg/m2
- •females must be of non-childbearing potential
排除标准
- •tattoos or other skin findings on any of the potential injection sites
- •history of chronic muscle pain within 30 days prior to study treatment
- •prior history of IgG1 therapy
- •Other protocol defined inclusion and exclusion criteria apply
研究组 & 干预措施
Treatment A: RO7239361
Active Comparator
RO7239361 subcutaneous injections on specified days; abdomen
干预措施: RO7239361 (Drug)
Treatment B: RO7239361
Active Comparator
RO7239361 subcutaneous injections on specified days; arm
干预措施: RO7239361 (Drug)
Treatment C: RO7239361
Active Comparator
RO7239361 subcutaneous injections on specified days; thigh
干预措施: RO7239361 (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax)
时间窗: Up to 92 days
AUC from time zero to time of last quantifiable concentration [AUC(0-T)]
时间窗: Up to 92 days
AUC from time zero extrapolated to infinite time [AUC(INF)]
时间窗: Up to 92 days
次要结局
- Change from baseline in physical examination findings(Up to 92 days)
- Change from baseline in clinical laboratory test findings(Up to 92 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 92 days)
- Change from baseline in electrocardiogram findings(Up to 92 days)
- Incidence of Adverse Events ( AEs)(Up to 92 days)
研究者
研究点 (1)
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