A Single Centre, Double Blinded, Randomised, Parallel Arm, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of MT1988 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The goal of this clinical trial is to assess the tolerability and amount of drug in the blood when four dose levels of MT1988 are administered for 14 days to healthy volunteers. The main question it aims to answer is:
- what side effects are seen while administering MT1988 for 14 days?
- how much of MT1988 can be measured in the blood at the beginning and end of administering MT1988 for 14 days?
Researchers will include a placebo arm (dummy drug) to compare the side effects.
Participants will:
- take MT1988 every day for 14 days
- visit the clinic once per week for assessments
- keep a diary to record information between clinic appointments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
- •providing informed consent
- •for females of child-bearing potential with fertile male partner - willing to comply with contraception requirements
排除标准
- •no current or past condition which may compromise the study objectives or participant safety
- •no clinically significant finding at screening, including physical examination, blood tests, medical history, concomitant medication
- •history of drug abuse or dependence within the previous 2 years
研究组 & 干预措施
MT1988 Dose 1
MT1988 Dose Level 1 (oral, twice daily)
干预措施: MT1988 (Drug)
MT1988 Dose 2
MT1988 Dose Level 2 (oral, twice daily)
干预措施: MT1988 (Drug)
MT1988 Dose 3
MT1988 Dose Level 3 (oral, twice daily)
干预措施: MT1988 (Drug)
MT1988 Dose 4
MT1988 Dose Level 4 (oral, twice daily)
干预措施: MT1988 (Drug)
Placebo
Placebo (oral, twice daily)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: From Day 1 to end of follow up (Day 21-28)
Data will be analysed using descriptive statistics across four dose levels and versus placebo.
次要结局
- Pharmacokinetics of single dose of MT1988 across four dose levels - Cmax(Days 1-2)
- Pharmacokinetics of multiple doses of MT1988 across four dose levels - Cmax(Days 14 to 17)
- Pharmacokinetics of single doses of MT1988 across four dose levels - Tmax(Days 1-2)
- Pharmacokinetics of multiple doses of MT1988 across four dose levels - Tmax(Days 14 to 17)
- Pharmacokinetics of single doses of MT1988 across four dose levels - AUC(Days 1-2)
- Pharmacokinetics of multiple doses of MT1988 across four dose levels - AUC(Days 14 to 17)