NL-OMON51342已完成不适用
A two-part, single dose, randomized, single-blinded, placebo controlled, phase I study to assess the safety and pharmacokinetics of oral MT1980 in healthy volunteers when dosed in the fasted state - Safety and CSF sampling PK study of MT1980 vs placebo
Monument Therapeutics Limited0 个研究点目标入组 26 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Sex: male or female; females may be of childbearing potential, of
- •nonchildbearing potential, or postmenopausal.
- •2. Age: 18 to 65 years, inclusive, at screening.
- •3. Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening.
- •4. Weight: >=50 kg and <=100 kg, inclusive, at screening.
- •5. At screening, females must not be pregnant or lactating, or must be of
- •nonchildbearing potential (either surgically sterilized or physiologically
- •incapable of becoming pregnant, or at least 1 year postmenopausal [follicle
- •stimulating hormone testing]); nonpregnancy will be confirmed for all females
- •by a negative serum pregnancy test at screening, and admission.
排除标准
- •1. Previous randomization in the current study.
- •2. Participation in a drug study within 30 days prior to drug administration in
- •the current study. Participation in 4 or more other drug studies in the 12
- •months prior to drug administration in the current study.
- •3. Subjects who are contract research organization (CRO) employees, or
- •immediate family members of a clinical research center or Sponsor employee.
- •4. History of drug or alcohol dependency or abuse (including soft drugs like
- •cannabis products) within the 2 years prior to screening.
- •5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
- •equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
研究者
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