A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food on This Profile in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.
详细描述
This is a first-in-human study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy caucasian subjects aged 18-45 years inclusive
- •Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.
排除标准
- •Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.
- •Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.
研究组 & 干预措施
E
ONO-4053
干预措施: ONO-4053 (Drug)
P
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.
时间窗: At protocol-specified timepoints before and after study drug administration up to Day 14
次要结局
- Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters(At protocol-specified timepoints before and after study drug administration up to Day 14)