A Double-blind, Single and Multiple Ascending Dose, Randomised, Placebo-controlled Study, in Healthy Adult and Elderly Subjects Exploring Safety, Tolerability, Pharmacokinetics of ONO-4474 and Pharmacology of ONO-4474 in NGF-hyperalgesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events
研究概览
简要总结
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.
详细描述
A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 18-55 years inclusive (Parts A and C); healthy male and female subjects aged 18-55 years inclusive (Part B); healthy male and female subjects aged 65 and over (Part D)
- •Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive
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
Experimental: ONO-4474 Part A1
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: ONO-4474 Part A1 (Drug)
Experimental: ONO-4474 Placebo Part A1
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: Placebo Part A1 (Drug)
Experimental: ONO-4474 Part A2
Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: ONO-4474 Part A2 (Drug)
Experimental: ONO-4474 Placebo Part A2
Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: Placebo Part A2 (Drug)
Experimental: ONO-4474 Part B
Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: ONO-4474 Part B (Drug)
Experimental: ONO-4474 Placebo Part B
Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: Placebo Part B (Drug)
Experimental: ONO-4474 Part C
NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design
干预措施: ONO-4474 Part C (Drug)
Experimental: ONO-4474 Placebo Part C
NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design
干预措施: Placebo Part C (Drug)
Experimental: ONO-4474 Part D
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: ONO-4474 Part D (Drug)
Experimental: ONO-4474 Placebo Part D
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
干预措施: Placebo Part D (Drug)
结局指标
主要结局
Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events
时间窗: Up to Day 28
次要结局
- Maximum plasma concentration of ONO-4474 (Cmax)(Day 1 and at Day 7)
- ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)(Day 1 and at Day 7)
- Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474(Day 1 and at Day 7)
- Plasma Decay half life (T1/2) of ONO-4474(Day 1 and at Day 7)
- Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale(3hr and 24hr after NGF injection)
- Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection.(3hr and 24hr after NGF injection)