An Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Different Subcutaneously-Administered JNJ-64304500 Formulations in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Area Under the Serum Concentration - Time Curve From Time Zero to Time Infinity (AUC [0-infinity]) of JNJ-64304500
研究概览
简要总结
The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.
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 60 Years（Adult）
- 性别
- All
- 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
JNJ 64304500: Reference
Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 reference formulation.
干预措施: JNJ 64304500 (Drug)
JNJ 64304500: Test
Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 test formulation.
干预措施: JNJ 64304500 (Drug)
结局指标
主要结局
Area Under the Serum Concentration - Time Curve From Time Zero to Time Infinity (AUC [0-infinity]) of JNJ-64304500
时间窗: Up to Day 113
AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
Maximum Observed Serum Concentration (Cmax) of JNJ-64304500
时间窗: Up to Day 113
Cmax is the maximum observed serum concentration.
次要结局
- Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters(Up to Day 113)
- Number of Participants with Clinically Significant Abnormalities in Vital Signs(Up to Day 113)
- Number of Participants with Clinically Significant Abnormalities in Physical Examinations(Up to Day 113)
- Number of Participants with Serum Antibodies to JNJ-64304500(Up to Day 113)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 113)