A Phase 1, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses and Food Effect of NS-136 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Number of Participants with Treatment-Related Adverse Events
研究概览
简要总结
The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:
- Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?
- What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm1
NS-136 SAD Dose 1
干预措施: NS-136 tablet (Drug)
Arm2
NS-136 SAD Dose 2
干预措施: NS-136 tablet (Drug)
Arm3
NS-136 SAD Dose 3
干预措施: NS-136 tablet (Drug)
Arm4
NS-136 SAD Dose 4
干预措施: NS-136 tablet (Drug)
Arm5
Arm5 NS-136 MAD Dose 1
干预措施: NS-136 tablet (Drug)
Arm6
Arm5 NS-136 MAD Dose 2
干预措施: NS-136 tablet (Drug)
Arm7
FE Grp A
干预措施: NS-136 tablet (Drug)
Arm8
FE Grp B
干预措施: NS-136 tablet (Drug)
Arm9
NS-136 SAD Dose 1 PBO
干预措施: Placebo (Drug)
Arm10
NS-136 SAD Dose 2 PBO
干预措施: Placebo (Drug)
Arm11
NS-136 SAD Dose 3 PBO
干预措施: Placebo (Drug)
Arm12
NS-136 SAD Dose 4 PBO
干预措施: Placebo (Drug)
Arm13
NS-136 MAD Dose 1 PBO
干预措施: Placebo (Drug)
Arm14
NS-136 MAD Dose 2 PBO
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events
时间窗: for SAD, day 1-7; for MAD, day 1-26, for FE, day1-14
Main pharmacokinetic parameters
时间窗: for SAD, day 1-7; for MAD, day 1-26,
Cmax
次要结局
未报告次要终点