Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Body weight [Safety and Tolerability]
研究概览
简要总结
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.
详细描述
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and Caucasian healthy adult male subjects. In addition, in Japanese healthy adult male subjects, to investigate dosing condition of Keyhole limpet hemocyanin (KLH) and to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion after treating with KLH.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy adult male subjects (PartA, B, and C)
- •Caucasian healthy adult male subjects (Part D)
- •Age (at the time of informed consent): ≥20 yeas, ≤ 45 yeas
- •Body weight (at the time of screening test): ≥50 kg
排除标准
- •Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
- •Subjects with current or with a history of severe allergy to drugs or foods
- •Subjects with current or with a history of drug or alcohol abuse
结局指标
主要结局
Body weight [Safety and Tolerability]
时间窗: Up to 84 days
Summary statistics of body weight
Vital sign [Safety and Tolerability]
时间窗: Up to 84 days
Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2
ECG parameter test [Safety and Tolerability]
时间窗: Up to 84 days
Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF)
Adverse events [Safety and Tolerability]
时间窗: Up to 84 days
Number of participants with adverse events as assessed by CTCAE v5.0
Laboratory test [Safety and Tolerability]
时间窗: Up to 84 days
Summary statistics of laboratory test (hematologic test, blood biochemistry test, blood coagulation test, immunoserologic test urinalysis)
Body temperature [Safety and Tolerability]
时间窗: Up to 84 days
Summary statistics of body temperature
次要结局
- Vss [Pharmacokinetic] (PartA, C, and D)(Up to 84 days)
- Cmax [Pharmacokinetic] (PartA, C, and D)(Up to 84 days)
- AUC [Pharmacokinetic] (PartA, C, and D)(Up to 84 days)
- T1/2 [Pharmacokinetic] (PartA, C, and D)(Up to 84 days)
- Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D)(Up to 84 days)
- Immunogenicity (PartA, C, and D)(Up to 84 days)
- Tmax [Pharmacokinetic] (PartA, C, and D)(Up to 84 days)
- CL [Pharmacokinetic] (PartA, C, and D)(Up to 84 days)
- Hemocyte test [Pharmacodynamics] (PartA, C, and D)(Up to 84 days)
- Pharmacodynamics (Part B and C)(Up to 84 days)